{"jobs":[{"absolute_url":"https://job-boards.greenhouse.io/criticalinnovations/jobs/4114028009","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":4077618009,"location":{"name":"US-Lawndale "},"metadata":null,"id":4114028009,"updated_at":"2026-04-21T01:00:12-04:00","requisition_id":"7","title":"Director of CMC","company_name":"Critical Innovations ","first_published":"2026-01-30T18:19:36-05:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Overview\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Director of CMC is responsible for day-to-day leadership and execution of Critical Innovations’ Chemistry, Manufacturing, and Controls (CMC) activities, with primary oversight over analytical development, CMC strategy, and CMC program management. This position plays a key role in ensuring that the Company’s drug-led products meet internal scientific standards and applicable regulatory requirements.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Director of CMC leads the development, optimization, qualification, and transfer of analytical methods; oversees CMC documentation and regulatory-support activities; and provides cross-functional coordination to ensure alignment between other departmental partners. This position does not oversee formulation or process development but collaborates closely with those teams to ensure analytical readiness, CMC coherence, and timely development support.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The ideal candidate possesses strong analytical chemistry/scientific expertise, excellent technical writing capabilities, a proven track record in CMC or analytical development for pharmaceuticals and/or combination products, and a deep familiarity with CMC regulatory expectations (e.g., 21 CFR Parts 210/211, 21 CFR Part 4, ICH Q8–Q11). The Director of CMC must be able to work independently, manage multiple projects, and operate effectively in a lean organization with extensive interaction with external contract research organizations (CROs) and cross-functional internal teams.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This position is designated as a full-time on-site role and is expected to be performed primarily at the Company’s assigned work location. Any work-from-home, hybrid, telecommuting, or other flexible work arrangement is available only if approved under applicable Company policies and business needs, and may be modified, suspended, or discontinued by the Company at any time, consistent with applicable law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Reports to:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;VP of Research\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Duties and Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The responsibilities of the Director of CMC typically include:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;u\u0026gt;Analytical Development Oversight\u0026lt;/u\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Oversee development, optimization, qualification, and transfer of analytical methods for drug substance and drug product testing.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop and manage analytical method lifecycle activities, including aging studies, purity and potency assays, impurity profiling, and device-related analytical evaluations (e.g., extractables/ leachables, dose delivery assessments).\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee outsourced analytical work, including method development, sample coordination, submission, review, and interpretation of test reports.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure analytical documentation meets internal and regulatory standards, including method development reports, validation protocols, and method transfer packages.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;u\u0026gt;CMC Strategy\u0026lt;/u\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Support the Vice President of Research in establishing the Company’s end-to-end CMC development and regulatory strategy.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Define analytical acceptance criteria and control strategies aligned with Critical Quality Attributes (CQAs), product requirements, and clinical needs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to risk assessments related to analytical methods, stability, and drug–device compatibility.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure that analytical development aligns with combination-product requirements, including interactions between drug and device materials.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;u\u0026gt;CMC Program Management\u0026lt;/u\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Manage CMC timelines, milestones, deliverables, and cross-functional coordination.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Track and communicate progress on analytical development, stability studies, and CMC regulatory activities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Coordinate CMC activities with other departments.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support planning and execution of CMC-related activities at CROs and Contract Development and Manufacturing Organizations (CDMOs).\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;u\u0026gt;Regulatory Support\u0026lt;/u\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Draft, review, and contribute to CMC sections of regulatory submissions (e.g., IND Module 3), method descriptions, stability summaries, analytical justification narratives, and combination-product integration sections.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to development of CMC regulatory strategy.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide analytical and CMC subject-matter expertise during regulatory interactions.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee the maintenance of accurate documentation for analytical methods, test results, and CMC records in compliance with quality system requirements.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;u\u0026gt;Cross-Functional Collaboration\u0026lt;/u\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Collaborate with engineering and quality/regulatory to ensure analytical and CMC readiness for combination-product development.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support process and formulation development teams by providing analytical insight, specifications, and method support needed for process work.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Participate in Management Review activities as requested.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;u\u0026gt;Compliance and Documentation\u0026lt;/u\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Perform and document all work in accordance with ISO 13485:2016, FDA’s Quality Management System Regulation (21 CFR Part 820), cGMP (21 CFR Parts 210 and 211), combination-product requirements (21 CFR Part 4), GLP, and internal Quality procedures.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee maintenance of analytical-related records within product history files and Design History File components relevant to the drug constituent part.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Skills and Experience:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Excellent written and oral communication skills.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong analytical and problem-solving abilities related to pharmaceutical analysis.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Track record of experience in direct management of key activities related to CMC development and strategy.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with CMC activities for combination products preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Extensive experience in analytical method development, optimization, and troubleshooting to support small- and large-molecule characterization.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven track record in analytical method development, optimization, and troubleshooting.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience leading a team of other scientists.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated leadership for outsourced analytical work at CROs/CDMOs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proficiency in generating and reviewing CMC documentation for regulatory submissions.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to work cross-functionally with scientific, engineering, and regulatory personnel.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong organization and time-management skills, with the ability to manage multiple concurrent tasks.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proficiency with Microsoft Office Suite.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Education and Training:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;PhD or MS in analytical chemistry, pharmaceutical sciences, chemical engineering, or a related scientific discipline.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;7+ years of experience in CMC or analytical development for pharmaceuticals and/or combination products preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience supporting IND or equivalent regulatory submissions preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience working within ISO 13485 and FDA-regulated environments preferred.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;Critical Innovations is an Affirmative Action/Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veterans\u0026#39; status, or any other characteristic protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;To conform to U.S. Government Department of Defense regulations, you must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Benefits:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401(k) Safe Harbor Plan\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Insurance:\u0026amp;nbsp;Medical, Dental and Vision\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Other Insurance: Life Insurance and Long-Term Disability (LTD) Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Time Off: Paid Time Off (PTO), Paid Sick Leave, Paid Holidays, and Paid Bereavement Leave\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Reimbursement Program\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Performance Bonus\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Incentive Unit Plan\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Flexible Schedule\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lunches, Snacks, Events\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Schedule:\u0026lt;/strong\u0026gt;\u0026lt;br\u0026gt;Monday to Friday\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Salary:\u0026lt;/strong\u0026gt;\u0026lt;br\u0026gt;$140,000 -180,000\u0026amp;nbsp;per year\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;a href=\u0026quot;https://www.criticalinnovations.com/privacy-policy\u0026quot;\u0026gt;Privacy Policy | Critical Innovations\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;","departments":[{"id":4003291009,"name":"Research and Laboratory","child_ids":[],"parent_id":null}],"offices":[{"id":4003176009,"name":" Lawndale","location":"California, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/criticalinnovations/jobs/4130176009","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":4085749009,"location":{"name":"US-Lawndale "},"metadata":null,"id":4130176009,"updated_at":"2026-04-28T16:11:05-04:00","requisition_id":"9","title":"Director of Preclinical \u0026 Clinical Science","company_name":"Critical Innovations ","first_published":"2026-02-13T14:41:37-05:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Overview\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Director of Preclinical \u0026amp;amp; Clinical Science is responsible for guiding Critical Innovations’ preclinical, translational, and clinical-development strategy across the Company’s product-development lifecycle. This role provides scientific leadership for preclinical research, translational evidence planning, early clinical-development strategy, clinical-study readiness, and scientific support for regulatory and sponsor-facing activities.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Director will lead the Company’s Preclinical \u0026amp;amp; Clinical Science function and will spearhead growing a team to provide this company capability. The role requires the ability to translate product-development questions into scientifically sound preclinical and clinical strategies, evaluate clinical relevance and evidence sufficiency, and coordinate effectively with internal and external subject matter experts.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Director will support the design and oversight of preclinical and clinical studies, including studies conducted through external CROs, testing laboratories, clinical sites, investigators, consultants, universities, military facilities, or other collaborators. The role will contribute to study strategy, protocol development, endpoint selection, data interpretation, scientific reporting, regulatory-support documentation, and sponsor-facing technical communications.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Director of Preclinical \u0026amp;amp; Clinical Science ensures that scientific, preclinical, translational, and clinical work is aligned with applicable regulatory expectations for medical devices, pharmaceuticals, and combination products. Relevant frameworks may include FDA’s Quality System Regulation, cGMP requirements, GLP, GCP, ISO 13485, ISO 10993, design controls, risk management, human subjects protections, and applicable clinical-study requirements.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This position is designated as a full-time on-site role and is expected to be performed primarily at the Company’s assigned work location. Any work-from-home, hybrid, telecommuting, or other flexible work arrangement is available only if approved under applicable Company policies and business needs, and may be modified, suspended, or discontinued by the Company at any time, consistent with applicable law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Reports to:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;CEO\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Duties and Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The responsibilities of the Director of Preclinical \u0026amp;amp; Clinical Science typically include the following.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Scientific, Preclinical, and Translational Leadership\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Lead the Company’s preclinical, translational, and clinical-development science strategy for medical device, pharmaceutical, and combination-product programs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee and support scientific research activities performed by or for Critical Innovations, including preclinical studies, translational research, biomarker planning, bench studies, cadaver studies, animal studies, and clinical-readiness activities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide management support to personnel within the Preclinical \u0026amp;amp; Clinical Science branch.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Translate product-development questions into scientifically sound preclinical and clinical evidence strategies.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure preclinical research, including bench testing and animal studies, is aligned with clinical feasibility, regulatory expectations, product requirements, and intended clinical use.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee or substantively contribute to preclinical study protocols, translational plans, testing strategies, endpoint selection, data analyses, scientific reports, and regulatory-support documentation.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Evaluate the scientific quality, clinical relevance, biological plausibility, statistical rationale, and regulatory appropriateness of proposed studies.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Identify study risks, scientific limitations, documentation gaps, and evidence deficiencies before execution.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Interpret preclinical and translational data in the context of product development, risk management, regulatory strategy, clinical feasibility, and sponsor deliverables.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Clinical Development and Clinical-Study Leadership\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Lead early clinical-development strategy, including clinical rationale, clinical-use case definition, endpoint selection, eligibility criteria, study design, and evidence-generation planning.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support the design, planning, execution, and oversight of sponsor-led clinical studies.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assist with the development and review of clinical protocols, investigator materials, informed consent forms, clinical study plans, clinical sections of regulatory submissions, and clinical-study reports.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide clinical and scientific input for device usability, human factors considerations, training materials, clinical-use risk assessments, and product-performance claims.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Coordinate with investigators, clinical sites, CROs, monitors, statisticians, consultants, medical advisors, regulatory personnel, and other external partners.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure appropriate oversight of outsourced GCP studies, including study conduct, documentation, monitoring follow-up, protocol deviations, adverse event workflows, data quality, and closeout activities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Coordinate with qualified medical monitors, physicians, clinical investigators, or other medical experts.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support evaluation of clinical safety information, adverse events, protocol deviations, clinical-risk signals, and related documentation in collaboration with Regulatory Affairs, Quality, investigators, and medical advisors.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Regulatory, Quality, and Documentation Support\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Contribute scientific, preclinical, translational, and clinical content to regulatory submissions and related communications.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Participate in regulatory meetings as one of the Company’s scientific/clinical-development representatives, as appropriate.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support documentation relevant to design controls, DHF content, risk management, clinical evaluation, preclinical evidence, product lifecycle requirements, and sponsor deliverables.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure study-related documentation is complete, traceable, scientifically justified, and suitable for regulated product-development use.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate with Quality Assurance and Regulatory Affairs to ensure that preclinical and clinical evidence packages are aligned with applicable requirements and expectations.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support internal reviews of protocols, study reports, data packages, scientific summaries, manuscripts, abstracts, technical memoranda, and regulatory-support documents.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maintain awareness of relevant regulatory and quality frameworks, which may include GLP, GCP, ISO 13485, ISO 10993, FDA Quality System Regulation, 21 CFR Part 4, 21 CFR Parts 210 and 211, and other applicable standards or guidance.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Skills and Experience:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Director of Preclinical \u0026amp;amp; Clinical Science should possess the following abilities to support medical technology development through clinical evaluation:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;7+ of relevant experience in medical device, pharmaceutical, and/or\u0026amp;nbsp;combination product translational (preclinical and clinical) research.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience contributing to or overseeing preclinical and clinical study design, protocol development, endpoint selection, study execution, data interpretation, scientific reports, regulatory-support documentation, and cross-functional development decisions.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong understanding of translational research, preclinical study design, clinical-development strategy, and early-stage product evidence generation.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience in trauma, emergency medicine, critical care, resuscitation, hemostasis, military medicine, or related fields preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Familiarity with FDA-regulated product development, including GCP, GLP, ISO 13485, ISO 10993, IRB processes, IACUC/ACURO processes, and sponsor-side clinical-study obligations preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to evaluate clinical and preclinical data, including study limitations, biological relevance, clinical significance, data quality, adverse findings, protocol deviations, and risk implications.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong scientific judgment and ability to conceptualize scientific hypotheses, translational strategies, clinical evidence plans, and practical study designs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to identify and mitigate product-related clinical, usability, translational, preclinical, and regulatory risks.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong leadership, mentoring, and cross-functional collaboration skills.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent written and oral communication skills, including the ability to contribute to protocols, technical reports, regulatory summaries, grant proposals, sponsor reports, manuscripts, abstracts, presentations, and internal scientific memoranda.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to work cross-functionally with scientific, engineering, manufacturing, quality, regulatory, clinical, grants/contracts, and business teams.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Self-motivated with strong time-management and organizational skills.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to work independently, prioritize multiple projects, address complex issues, and operate within a fast-paced, hands-on environment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Highly organized, detail-oriented, and capable of maintaining documentation consistent with regulatory requirements\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Education and Training:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Advanced degree required in a relevant scientific, clinical, medical, veterinary, pharmaceutical, biomedical engineering, physiology, neuroscience, translational science, or related discipline.\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Acceptable degrees include PhD, MD/DO, DVM, PharmD, or equivalent advanced scientific or clinical training\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Additional training or experience in clinical research, translational medicine, medical device development, combination-product development, biostatistics, regulatory science, GLP/GCP, human subjects research preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Authorization to work in the United States indefinitely without restriction or sponsorship is required, subject to any applicable export-control or government-contract requirements.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;Critical Innovations is an Affirmative Action/Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veterans\u0026#39; status, or any other characteristic protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;To conform to U.S. Government Department of War regulations, you must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Benefits:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401(k) Safe Harbor Plan\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Insurance:\u0026amp;nbsp;Medical, Dental and Vision\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Other Insurance: Life Insurance and Long-Term Disability (LTD) Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Time Off: Paid Time Off (PTO), Paid Sick Leave, Paid Holidays, and Paid Bereavement Leave\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Reimbursement Program\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Performance Bonus\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Incentive Unit Plan\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Flexible Schedule\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lunches, Snacks, Events\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Schedule:\u0026lt;/strong\u0026gt;\u0026lt;br\u0026gt;Monday to Friday\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Salary:\u0026lt;/strong\u0026gt;\u0026lt;br\u0026gt;$160,000 - $200,000 per year\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;a href=\u0026quot;https://www.criticalinnovations.com/privacy-policy\u0026quot;\u0026gt;Privacy Policy | Critical Innovations\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;","departments":[{"id":4030495009,"name":"Preclinical \u0026 Clinical Science","child_ids":[],"parent_id":null}],"offices":[{"id":4003176009,"name":" Lawndale","location":"California, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/criticalinnovations/jobs/4184890009","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":4107140009,"location":{"name":"US-Lawndale "},"metadata":null,"id":4184890009,"updated_at":"2026-04-21T01:00:12-04:00","requisition_id":"10","title":"Human Resources Coordinator I","company_name":"Critical Innovations ","first_published":"2026-03-17T17:07:43-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Overview\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Human Resources Coordinator I works closely with and under the supervision of the Director of Human Resources to support the organization\u0026#39;s daily human resources operations. This role provides administrative and operational support across HR functions, including talent acquisition, onboarding, employee records management, compliance documentation, payroll coordination, and employee engagement initiatives.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This position plays a critical role in maintaining efficient HR processes, supporting the full employee lifecycle, and ensuring compliance with company policies and applicable employment regulations. The Human Resources Coordinator I helps create a positive experience through organized systems, timely communication, and effective administrative support.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The ideal candidate is highly organized, detail-oriented, proactive, and able to manage multiple responsibilities in a fast-paced environment while handling confidential information with discretion.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This position is designed as a full-time, on-site role and is expected to be performed primarily at the Company’s assigned work location. Any work-from-home, hybrid, telecommuting, or other flexible work arrangement is available only if approved under applicable Company policies and business needs, and may be modified, suspended, or discontinued by the Company at any time, consistent with applicable law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Reports to:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Director of Human Resources\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Duties and Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Human Resources Coordinator I responsibilities typically involve:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Human Resources Operations\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Provide day-to-day administrative and operational support to the Director of Human Resources.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support employee lifecycle activities, including onboarding, internal transitions, and offboarding processes.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assist in maintaining and updating employee records, HRIS systems, and personnel files to ensure accuracy, organization, and compliance with recordkeeping requirements.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Prepare, collect, and properly archive HR documentation (e.g., NDAs, offer letters, background checks, and onboarding paperwork).\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support benefits administration by assisting with employee enrollments, changes, and benefits-related inquiries.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assist with payroll coordination, timecard verification, and related documentation to support accurate payroll processing.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure HR documentation and processes comply with company policies, employment laws, and applicable federal contractor regulations.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assist with employee relations matters by coordinating documentation and communications as directed by the Director of Human Resources.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Coordinate HR-related meetings and maintain calendar oversight for HR initiatives and projects.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Talent Acquisition \u0026amp;amp; Recruiting Support\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Assist with job postings, resume screening, interview scheduling, and candidate communications.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Coordinate recruitment logistics, including interview coordination, candidate follow-ups, and hiring documentation.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maintain and update the applicant tracking system (ATS) and recruitment records.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support recruitment reporting, candidate tracking, and hiring metrics.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Coordinate onboarding logistics for new hires, consultants, and subject matter experts.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure completion of required onboarding documentation prior to employee start dates.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Accounts Payable \u0026amp;amp; Administrative Support\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Assist with the accounts payable process, vendor payments, and invoice tracking.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assist with employee expense submissions in compliance with company expense guidelines.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide general administrative support to the Director of Human Resources and assist with additional business-related duties as assigned.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Skills and Experience:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt; \u0026lt;/strong\u0026gt;2-3 years of related experience in human resources, recruiting, and administrative operations\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong understanding of HR operations, employee lifecycle processes, and employment regulations\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tech-Savvy, interested in digital HR solutions, continuous improvement, and workflow automation\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ideally familiar with Gusto or similar HRIS systems\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong analytical and problem-solving skills with the ability to interpret HR data and support informed decision-making\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent organizational skills with demonstrated ability to manage multiple tasks and priorities simultaneously\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;High attention to detail and accuracy in documentation and data management\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Self-motivated with strong time-management skills to meet deadlines in a fast-paced environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to handle confidential and sensitive information with professionalism and discretion\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience in supporting all stages of the recruitment and termination processes\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proficiency in Microsoft Office Suite (MS Word, Excel, Outlook, PowerPoint, etc.)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with ATS platforms (ideally Greenhouse), Expensify, Bill.com, Asana, and DocuSign\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent verbal and written communication skills\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Preferred Industry Experience (Helpful but Not Required)\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt; \u0026lt;/strong\u0026gt;Medical device research, development, and/or manufacturing, including ISO 13485 and Quality System (QS) Regulation\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Federal government contracting and/or Small Business grants\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Emergency medicine, trauma, and/or critical care fields\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Military operations, Department of Defense funding, Defense Contract Audit Agency (DCAA) accounting\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Education and Training:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s degree in Business Administration, Human Resources, or a related field required\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;Critical Innovations is an Affirmative Action/Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veterans\u0026#39; status, or any other characteristic protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;To conform to U.S. Government Department of Defense regulations, you must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Benefits:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401(k) Safe Harbor Plan\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Insurance:\u0026amp;nbsp;Medical, Dental and Vision\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Other Insurance: Life Insurance and Long-Term Disability (LTD) Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Time Off: Paid Time Off (PTO), Paid Sick Leave, Paid Holidays, and Paid Bereavement Leave\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Reimbursement Program\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Performance Bonus\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Incentive Unit Plan\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Flexible Schedule\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lunches, Snacks, Events\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Schedule:\u0026lt;/strong\u0026gt;\u0026lt;br\u0026gt;Monday to Friday\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Salary:\u0026lt;/strong\u0026gt;\u0026lt;br\u0026gt;$55,000 -$85,000 per year\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;a href=\u0026quot;https://www.criticalinnovations.com/privacy-policy\u0026quot;\u0026gt;Privacy Policy | Critical Innovations\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;","departments":[{"id":4003290009,"name":"Human Resources","child_ids":[],"parent_id":null}],"offices":[{"id":4003176009,"name":" Lawndale","location":"California, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/criticalinnovations/jobs/4233817009","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":4136601009,"location":{"name":"US-Lawndale "},"metadata":null,"id":4233817009,"updated_at":"2026-04-28T16:42:39-04:00","requisition_id":null,"title":"Preclinical Scientist","company_name":"Critical Innovations ","first_published":"2026-04-27T19:21:15-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Overview\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Preclinical Scientist will coordinate, scientifically plan, analyze, and document preclinical studies for the Company. The role is intended for a scientist with graduate-level training and sufficient scientific judgment to translate product-development questions into practical, defensible preclinical study designs, while working with internal and external senior subject matter experts as needed.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The position will coordinate and scientifically support a range of primarily live-animal preclinical studies, and may also include related microbiology, animal cadaver or foodstuff testing, human cadaver testing, histopathology, biocompatibility, bench performance, and other translational studies. Most studies are expected to be performed off-site through external Contract Research Organizations (CROs), testing laboratories, universities, military facilities, or other subcontractors. Limited travel may be required for study initiation, in-life observations, troubleshooting, data review, or vendor oversight.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;In addition to coordinating study logistics, this position is responsible for providing scientific thinking and analysis across preclinical programs. This includes helping select appropriate animal models and endpoints, developing and reviewing scientifically sound protocols, anticipating study limitations, evaluating biological and statistical relevance, interpreting data in the context of device and combination-product development, and communicating conclusions to cross-functional teams.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Preclinical Scientist will serve as the coordination point for preclinical studies and will routinely coordinate with:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Internal to Critical Innovations\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Production \u0026amp;amp; Engineering (e.g., test devices, control devices, IFUs)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Quality Assurance \u0026amp;amp; Regulatory Affairs (e.g., study regulatory requirements, reporting review)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Technical Operations, including the R\u0026amp;amp;D Laboratory and CMC functions, for assay development, laboratory protocols, analytical methods, specimen processing, and CMC-related study support.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Grants \u0026amp;amp; Contracts, including contract-driven program management, milestone tracking, sponsor reporting requirements, and deliverable coordination.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Shipping and receiving (e.g., to send and receive control and test items, as needed)\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;External to Critical Innovations\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Contract Research Organizations (e.g., performance of studies)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Testing laboratory sites (e.g., testing setup, performance of specific tests on study specimens, histopathology)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Statisticians, consultants, and other subcontractors\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Military subject matter experts and/or facilities (as applicable)\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;This job will encompass the design, development, implementation, oversight, and management of a variety of preclinical animal studies of Critical Innovations’ products to ensure study goals (e.g., safety, efficacy, performance, biocompatibility) are met.\u0026amp;nbsp;It additionally includes the analysis of data received from the studies, as well as communicating findings internally and documenting them in applicable Design History Files in compliance with ISO 13485. Additionally, this position includes providing data and analysis for authorship of manuscript, abstracts, presentations, and intellectual property.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Familiarity and previous experience with relevant Regulatory requirements for devices and combination products that are either device- or drug-led (e.g., FDA’s Quality System Regulation 21 CFR Part 820, Good Laboratory Practices (GLP), ICH, cGMP for pharmaceutical products 21CFR Parts 210 and 211), Quality Management System ISO 13485:2016, ISO 10993 Biocompatibility are a significant benefit.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The ideal candidate will be able to think critically, identify study risks before execution, recognize scientific and documentation gaps, and communicate complex scientific findings in a practical manner for engineering, regulatory, quality, clinical, and management audiences. This position is expected to provide meaningful scientific input and independent analysis while also remaining hands-on with study coordination and execution.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This position is designated as an on-site role and is expected to be performed primarily at the Company’s assigned work location. Any work-from-home, hybrid, telecommuting, or other flexible work arrangement is available only if approved under applicable Company policies and business needs, and may be modified, suspended, or discontinued by the Company at any time, consistent with applicable law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Reports to:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Director of Preclinical \u0026amp;amp; Clinical Science\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Duties and Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The responsibilities of the Preclinical Scientist typically include:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Contribute to preclinical study planning, including model selection, endpoint definition, experimental controls, success criteria, sample size rationale, and study-risk assessment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop, review, and refine animal models and related test methods, in conjunction with internal and external expertise, to demonstrate product safety, efficacy, performance, usability, durability, biocompatibility, or mechanism of action.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Author and/or assist with scientific review of study protocols, amendments, data collection forms, study plans, acceptance criteria, final reports, regulatory submission sections, abstracts, manuscripts, presentations, and internal technical memoranda.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Participate in cross-functional preclinical strategy discussions and help translate product-development questions into testable hypotheses and practical experimental designs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Evaluate the scientific quality, regulatory appropriateness, and operational feasibility of CRO and laboratory proposals, including budgets, timelines, methods, endpoints, and deliverables.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Obtain quotes, prepare or support purchase orders, supervise subcontracted study work, process invoices, coordinate shipments, and support vendor payment for CROs and related vendors.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Coordinate and supervise external study execution, including study kickoff, test article preparation, shipping, in-life monitoring, protocol deviations, issue resolution, specimen handling, pathology review, data transfer, and closeout.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Analyze quantitative and qualitative study data; interpret biological, physiological, engineering, histopathological, microbiological, and performance findings; and communicate conclusions, limitations, and recommended next steps.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Identify and document study deviations, data anomalies, adverse findings, and technical risks; work with Quality, Regulatory, and Research leadership to determine impact and appropriate follow-up.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support regulatory strategy by preparing or reviewing preclinical testing content for FDA submissions and other regulatory deliverables, including rationale for test selection, GLP status, animal model relevance, and evidence sufficiency.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maintain applicable Design History File documentation, study records, raw data summaries, risk-analysis inputs, technical reports, and traceability to product requirements or program objectives.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate with Research \u0026amp;amp; Laboratory, Production \u0026amp;amp; Engineering, Quality \u0026amp;amp; Regulatory, Grants \u0026amp;amp; Contracts, and external subject matter experts to ensure study outputs meet technical, quality, regulatory, and sponsor needs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide scientific input for grant proposals, sponsor reports, peer-reviewed manuscripts, conference abstracts, presentations, patent disclosures, and intellectual property strategy.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support junior staff or coordinators by sharing scientific rationale, protocol-review feedback, data-interpretation input, documentation practices, and vendor-oversight practices.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;Skills and Experience:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt; \u0026lt;/strong\u0026gt;Sound scientific judgment and ability to apply the scientific method to translational research, device development, and preclinical animal studies.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience designing, executing, monitoring, coordinating, or analyzing preclinical animal studies, preferably involving medical devices, combination products, trauma, hemostasis, resuscitation, physiology, neuroscience, surgery, critical care, or related fields.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Working understanding of experimental design, appropriate controls, endpoint selection, biological variability, bias reduction, data integrity, and interpretation of preclinical findings.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to perform scientific data analysis, including descriptive statistics, graphical data review, outlier assessment, study-limitations analysis, and interpretation of statistical output.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent written communication, including the ability to author or substantively contribute to protocols, technical reports, regulatory summaries, manuscripts, abstracts, and internal scientific summaries.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong oral communication and ability to present scientific information to cross-functional technical and non-technical audiences.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience interacting with CROs, testing laboratories, vendors, consultants, pathologists, veterinarians, statisticians, government sponsors, or academic collaborators is preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Familiarity with one or more quality or compliance frameworks relevant to preclinical development, such as GLP, GMP, ISO 13485, FDA Quality System Regulation, ISO 10993, IACUC, ACURO, ICH, or related standards.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to work within controlled-document, design-control, and quality-system expectations, including disciplined document review, change control, traceability, and record retention.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong project-management capability, including schedule management, vendor oversight, issue escalation, milestone tracking, and completion of deliverables under defined timelines.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;High attention to detail and ability to identify discrepancies, scientific inconsistencies, missing controls, unsupported conclusions, and documentation gaps.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Self-motivated, highly organized, and able to work independently while coordinating effectively with a cross-functional team.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proficiency with Microsoft Office Suite. Experience with statistical, graphing, reference-management, electronic data capture, or quality-management tools is beneficial.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to travel occasionally for CRO site visits, study observations, sponsor meetings, or vendor oversight.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Education and Training:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Master\u0026#39;s degree or PhD in biology, physiology, neuroscience, veterinary science, biostatistics, or a related scientific discipline required. PhD preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;For candidates with a Master\u0026#39;s degree, typically 3+ years of relevant preclinical, translational research, medical device, biotechnology, pharmaceutical, or CRO experience is expected.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;For candidates with a PhD, relevant graduate, post-graduate, industry, CRO, translational, or applied preclinical research experience is expected; industry experience is preferred but not required.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Direct experience with preclinical animal study procedures, IACUC or ACURO submissions, GLP or non-GLP study justification, and external CRO oversight is preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Knowledge or experience with FDA preclinical expectations for medical devices or combination products, ISO 13485, ISO 10993, 21 CFR Part 820, 21 CFR Part 58, and/or 21 CFR Parts 210 and 211 is preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Authorization to work in the United States indefinitely without restriction or sponsorship is required.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;Critical Innovations is an Affirmative Action/Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veterans\u0026#39; status, or any other characteristic protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;To conform to U.S. Government Department of War regulations, you must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Benefits:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401(k) Safe Harbor Plan\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Insurance:\u0026amp;nbsp;Medical, Dental and Vision\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Other Insurance: Life Insurance and Long-Term Disability (LTD) Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Time Off: Paid Time Off (PTO), Paid Sick Leave, Paid Holidays, and Paid Bereavement Leave\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Reimbursement Program\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Performance Bonus\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Incentive Unit Plan\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Flexible Schedule\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lunches, Snacks, Events\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Schedule:\u0026lt;/strong\u0026gt;\u0026lt;br\u0026gt;Monday to Friday\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Salary:\u0026lt;/strong\u0026gt;\u0026lt;br\u0026gt;$115,000 – $155,000 per year\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;a href=\u0026quot;https://www.criticalinnovations.com/privacy-policy\u0026quot;\u0026gt;Privacy Policy | Critical Innovations\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;","departments":[{"id":4030495009,"name":"Preclinical \u0026 Clinical Science","child_ids":[],"parent_id":null}],"offices":[{"id":4003176009,"name":" Lawndale","location":"California, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/criticalinnovations/jobs/4225107009","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":4131689009,"location":{"name":"US-Lawndale "},"metadata":null,"id":4225107009,"updated_at":"2026-04-24T16:08:36-04:00","requisition_id":"11","title":"Proposal \u0026 Report Writer","company_name":"Critical Innovations ","first_published":"2026-04-23T12:47:56-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Overview\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Proposal and Report Writer works closely with and under the supervision of the Grants \u0026amp;amp; Contracts Coordinator I\u0026lt;strong\u0026gt; \u0026lt;/strong\u0026gt;to conduct tasks related to various aspects of the contract life cycle. This includes preparing and submitting contract reports, monitoring deadlines for contract deliverables, and assisting with preparation of additional written materials (e.g., slide decks, poster presentations, publications, proposals). The ideal candidate should have very strong technical writing skills and be detail focused, with an ability to ensure compliance with contract reports, federal submissions, and other technical writing. A history of grant and reporting writing for federal awards is very helpful.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This position is designated as an on-site role and is expected to be performed primarily at the Company’s assigned work location. Any work-from-home, hybrid, telecommuting, or other flexible work arrangement is available only if approved under applicable Company policies and business needs, and may be modified, suspended, or discontinued by the Company at any time, consistent with applicable law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Reports to:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Grants \u0026amp;amp; Contracts Coordinator I\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Duties and Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Proposal and Report Writer works closely with and under the supervision of the Grants \u0026amp;amp; Contracts Coordinator I to complete writing related tasks in the following categories:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Contract report writing\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Maintain a portfolio of grants and contracts to ensure timely reporting to applicable federal agencies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Help monitor and assure grant and contract compliance, including report submission (e.g. monthly, bimonthly, quarterly, yearly, final) and project deliverable monitoring\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop narrative reports and invoices, for submission after review by the Principal Investigator (PI) and/or Director of Grants \u0026amp;amp; Contracts and/or Grants \u0026amp;amp; Contracts Coordinator I\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Communicate with team members to receive and interpret information for the narrative reports. In parallel, convey information to team members regarding task activities and deadlines. Raise potential issues (e.g., schedule delays) to the attention of the Grants \u0026amp;amp; Contracts Coordinator I as needed.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Upload documents and interact with Government reporting websites (e.g. eBRAP) and Government representatives\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Federal proposal writing\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Help analyze government RFIs, RFQs, and RFPs to determine proposal requirements\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Help prepare initial proposal drafts by gathering and formatting information, inserting stock language, and gathering supporting information\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proof-read, format, and improve narrative text\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Upload documents to appropriate agencies and ensure on-time submission (e.g. DSIP, eBRAP, ATI2 BIDS, Grants.gov)\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Other research papers, presentations, communications\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Help with formatting and uploading submissions to peer review journals, following applicable journal guidelines.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assist with presentation preparation for pitch meetings and scientific conferences (e.g. white papers, slide decks, abstracts, posters).\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Skills and Experience:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt; \u0026lt;/strong\u0026gt;2-3 years of experience with technical proposal writing\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent writing, editing, and oral communication skills along with an ability to distill complex concepts into understandable language\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Highly organized and detailed oriented\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience working as part of a team to successfully manage multiple projects with competing timelines\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Self-motivated with strong time-management skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Expert with Microsoft Office Suite (Microsoft Word and Excel) is required\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with Small Business Innovation Research (SBIR) grants, MTEC, BAA, and/or contracts preferred, but not required\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Familiarity with emergency medicine, trauma, and/or critical care fields preferred, but not required\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Familiarity with military operations and/or funding a benefit, but not required\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Education and Training:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;BA/BS degree required, preferably in a scientific field.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;Critical Innovations is an Affirmative Action/Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veterans\u0026#39; status, or any other characteristic protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;To conform to U.S. Government Department of Defense regulations, you must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Benefits:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401(k) Safe Harbor Plan\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Insurance:\u0026amp;nbsp;Medical, Dental and Vision\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Other Insurance: Life Insurance and Long-Term Disability (LTD) Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Time Off: Paid Time Off (PTO), Paid Sick Leave, Paid Holidays, and Paid Bereavement Leave\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Reimbursement Program\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Performance Bonus\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Incentive Unit Plan\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Flexible Schedule\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lunches, Snacks, Events\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Schedule:\u0026lt;/strong\u0026gt;\u0026lt;br\u0026gt;Monday to Friday\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Salary\u0026lt;/strong\u0026gt;\u0026lt;br\u0026gt;$50,000 - $75,000 per year\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;a href=\u0026quot;https://www.criticalinnovations.com/privacy-policy\u0026quot;\u0026gt;Privacy Policy | Critical Innovations\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;","departments":[{"id":4003292009,"name":"Grants \u0026 Contracts","child_ids":[],"parent_id":null}],"offices":[{"id":4003176009,"name":" Lawndale","location":"California, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/criticalinnovations/jobs/4119140009","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":4080906009,"location":{"name":"US-Lawndale "},"metadata":null,"id":4119140009,"updated_at":"2026-04-21T01:00:12-04:00","requisition_id":"8","title":"Senior Quality Engineer I","company_name":"Critical Innovations ","first_published":"2026-02-11T16:00:53-05:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Overview\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Senior Quality Engineer is instrumental in establishing and upholding quality control measures throughout our product and process development lifecycle, and production activities to ensure manufacture of high quality and reliable products.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This role entails close collaboration with Engineering \u0026amp;amp; Production teams to create and execute impactful quality assurance strategies from the initial receiving phase to the release of the final product. This role includes oversight and management of quality inspections as well as equipment calibration, qualification and maintenance.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Senior Quality Engineer’s responsibilities fall under four main areas:\u0026lt;/p\u0026gt;\n\u0026lt;ol\u0026gt;\n\u0026lt;li\u0026gt;Management, development and validation of internal inspection processes, metrology and equipment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Evaluation of inspection and measurement systems, metrology techniques, and tooling using statistical measurement system analysis methods.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborating with cross-functional teams and suppliers to implement solutions, lead quality improvement initiatives and problem-solving efforts.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Management and oversight of quality inspections as well as equipment calibration and qualification.\u0026lt;/li\u0026gt;\n\u0026lt;/ol\u0026gt;\n\u0026lt;p\u0026gt;The Senior Quality Engineer will assist in the management and implementation of the Quality Management System to ensure compliance with ISO 13485 and the FDA’s Quality Management System Regulation 21 CFR Part 820.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Senior Quality Engineer will provide additional support to the Quality Management System’s activities as assigned at the discretion of management.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This position is designated as a full-time on-site role and is expected to be performed primarily at the Company’s assigned work location. Any work-from-home, hybrid, telecommuting, or other flexible work arrangement is available only if approved under applicable Company policies and business needs, and may be modified, suspended, or discontinued by the Company at any time, consistent with applicable law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Reports to:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Vice President of Quality Assurance \u0026amp;amp; Regulatory Affairs.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Duties and Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Senior Quality Engineer’s responsibilities typically involve:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Work closely with the Engineering \u0026amp;amp; Production teams to develop best practices and improve metrology and inspection techniques for product development, manufacturing processes, equipment and fixtures.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Evaluate inspection, measurement, and test equipment, metrology techniques, and tooling to ensure suitability for intended use and compliance with quality and regulatory requirements.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Plan, execute, and interpret Measurement System Analysis (MSA) studies, including Gage Repeatability and Reproducibility (Gage R\u0026amp;amp;R), Gage Linearity, and Gage Bias studies for capability and identify sources of variation related to equipment, methods, operators, or environment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate with the Engineering \u0026amp;amp; Production teams to establish necessary controls and verification/validation procedures for production processes.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop and implement manufacturing process controls, including in-process inspections and sampling plans for receiving in-process, and final inspection.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Responsible for supporting Engineering \u0026amp;amp; Production with problem solving, process improvements and resolution to product development and manufacturability issues.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review Engineering drawings and changes to assure that they are properly dimensioned and conform to GD\u0026amp;amp;T protocol and provide proper inspectability for the related components and assemblies.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Evaluation of changes to design and/or manufacturing process for impact to the Design History File. Leads and executes activities to close any gaps, such as additional verification testing or updates to risk documentation.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate with Engineering \u0026amp;amp; Production teams to develop and maintain the risk management program for the manufacturing processes.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead process validation efforts to ensure consistency and reliability in manufacturing outputs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Author process verification/validation protocols and reports.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assessing the need for new gages and equipment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Management of quality inspections as well as equipment calibration, qualification and maintenance.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support internal audits and external audits as needed.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead efforts to address nonconformities and Supplier Corrective Actions relating to custom-made components.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Participate in, or coordinate Corrective/Preventive Actions, investigations and root cause analysis.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Additional support for the Quality Management System activities as assigned.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;On a daily basis, assess overall workload for any area that needs help, and assist coworkers and provide backup as needed without being reassigned by management.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Skills and Experience:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Strong understanding of quality management systems and regulatory requirements in medical device manufacturing- (ISO 13485:2016, FDA 21 CFR 820).\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with process validation, statistical process control, and measurement system analysis.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proficiency in quality tools and methodologies (e.g., Kaizen events, Lean Manufacturing, FMEA).\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong understanding of metrology principles and evaluation of measurement accuracy, precision, repeatability, and reproducibility, using MSA.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to apply statistical analysis to measurement data and translate results into practical manufacturing and inspection improvements.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent analytical and problem-solving skills.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong communication and interpersonal skills.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to work effectively in a cross-functional team environment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Adaptability and resourcefulness to roll up sleeves and multitask in order to thrive in a global company environment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Highly organized and detailed oriented.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Education and Training:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s degree in engineering, Quality Assurance, or a related field (Master’s degree preferred).\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;7+ years of experience in quality engineering, preferably in the medical device industry.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;ASQ certification (CQE, CQA, or similar), preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with CAD software and GD\u0026amp;amp;T principles.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Familiarity with automation and Industry 4.0 concepts.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;Critical Innovations is an Affirmative Action/Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veterans\u0026#39; status, or any other characteristic protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;To conform to U.S. Government Department of Defense regulations, you must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Benefits:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401(k) Safe Harbor Plan\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Insurance:\u0026amp;nbsp;Medical, Dental and Vision\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Other Insurance: Life Insurance and Long-Term Disability (LTD) Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Time Off: Paid Time Off (PTO), Paid Sick Leave, Paid Holidays, and Paid Bereavement Leave\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Reimbursement Program\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Performance Bonus\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Incentive Unit Plan\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Flexible Schedule\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lunches, Snacks, Events\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Schedule:\u0026lt;/strong\u0026gt;\u0026lt;br\u0026gt;Monday to Friday\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Salary\u0026lt;/strong\u0026gt;\u0026lt;br\u0026gt;$110,000-$150,000 per year\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;a href=\u0026quot;https://www.criticalinnovations.com/privacy-policy\u0026quot;\u0026gt;Privacy Policy | Critical Innovations\u0026lt;/a\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;","departments":[{"id":4003265009,"name":"Quality and Regulatory","child_ids":[],"parent_id":null}],"offices":[{"id":4003176009,"name":" Lawndale","location":"California, United States","child_ids":[],"parent_id":null}]}],"meta":{"total":6}}