{"jobs":[{"absolute_url":"https://job-boards.greenhouse.io/kaleo/jobs/7723918003","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":5759739003,"location":{"name":"Richmond, VA"},"metadata":null,"id":7723918003,"updated_at":"2026-06-18T12:25:19-04:00","requisition_id":"233","title":"AI Transformation Specialist","company_name":"Kaléo","first_published":"2026-05-04T16:21:10-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;This is a 3‑month temporary role with the strong potential to convert to a full-time employee.\u0026amp;nbsp; The AI Transformation Specialist will report into the SVP of AI Transformation.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kaléo is accelerating the practical use of Artificial Intelligence across the enterprise — and we’re hiring an \u0026lt;strong\u0026gt;AI Transformation Specialist\u0026lt;/strong\u0026gt; to help turn AI ideas into real, usable solutions.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This is a hands‑on, execution‑focused role for someone who already uses AI tools daily and wants to apply them to real business problems. You do not need prior “AI transformation” experience, coding skills, or pharma background. You do need curiosity, strong problem-solving instincts, and a bias toward action.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This is a 3‑month temporary role with a clear path to a permanent position based on performance and business need.\u0026amp;nbsp; The opportunity will provide you with meaningful ownership and visibility early in your career, early exposure to interacting with senior leadership for enterprise-level strategy, and provide an opportunity to shape how AI is used across an organization.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;As the AI Transformation Specialist, you will:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Bring AI Into Everyday Work\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Partner with teams (Finance, HR, Operations, Commercial, Legal, etc.) to identify practical opportunities for AI to save time and reduce friction.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Use existing AI tools (e.g., Copilot, ChatGPT Enterprise, approved internal tools) to:\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Draft and refine content\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Summarize and synthesize information\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Analyze data and trends\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Improve manual or repetitive workflows\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;li\u0026gt;Build simple prototypes, examples, or demos to show what’s possible.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Turn Ideas Into Execution\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Help move AI use cases from “interesting idea” to real pilots and daily usage.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Test, iterate, and refine solutions based on user feedback.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Track progress and follow through—this role is about \u0026lt;strong\u0026gt;execution, not just ideation\u0026lt;/strong\u0026gt;.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Partner Across the Organization\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Work closely with the AI Transformation team and functional leaders to support priority initiatives.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Translate business needs into clear, practical AI use cases using plain language.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Coordinate with stakeholders to keep initiatives moving while operating within approved guardrails.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Learn Fast and Share What Works\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Learn Kaléo’s business quickly and understand where time and effort are being wasted.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Stay curious about new AI capabilities and think creatively about internal applications.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Share wins, lessons learned, templates, and best practices to support broader adoption.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;To be considered for the position, you must have:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;0–3 years of professional experience or a recent college graduate.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong, hands‑on experience using AI tools (e.g., Copilot, ChatGPT, or similar AI assistants) in real workflows.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Comfort experimenting with AI and figuring things out independently.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Exposure to business operations, analytics, process improvement, or digital tools.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience working in a structured or regulated environment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Bias toward action — you enjoy building, testing, and iterating.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Clear communicator who can work with people across functions and levels.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Organized, reliable, and able to follow through on commitments.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;","departments":[{"id":4024282003,"name":"Human Resources","child_ids":[],"parent_id":null}],"offices":[{"id":4015692003,"name":"Corporate Remote","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kaleo/jobs/7749503003","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":5771087003,"location":{"name":"Remote"},"metadata":null,"id":7749503003,"updated_at":"2026-06-17T12:36:04-04:00","requisition_id":"234","title":"Director, Combination Product Development and Human Factors Engineering","company_name":"Kaléo","first_published":"2026-05-27T11:47:43-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;This is a remote opportunity with occasional travel, estimated at less than 25%.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kaléo is a global leader in drug‑delivery device technology and auto‑injector innovation, providing millions of patients, government partners, and emergency responders with security and peace of mind.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;​\u0026lt;/span\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;​\u0026lt;/span\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;The \u0026lt;strong\u0026gt;\u0026lt;span data-teams=\u0026quot;true\u0026quot;\u0026gt;Director, Combination Product Development and Human Factors Engineering\u0026lt;/span\u0026gt;\u0026lt;/strong\u0026gt;\u0026amp;nbsp;is responsible for managing the development\u0026lt;/span\u0026gt;\u0026lt;span data-ccp-props=\u0026quot;{}\u0026quot;\u0026gt; of \u0026lt;/span\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;new combination products including design, development, and human factor studies through design transfer into manufacturing. The individual should be involved in building Kaleo’s intellectual property portfolio development. The Director will support the senior leadership team with critical information to make informed decisions on the selection of key partners, risks, and identification of critical milestones (budgeting, R\u0026amp;amp;D build strategy, etc).\u0026lt;/span\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;​\u0026lt;/span\u0026gt;\u0026lt;span data-ccp-props=\u0026quot;{}\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span class=\u0026quot;ContentControlBoundarySink SCXW76625767 BCX8\u0026quot; lang=\u0026quot;EN-US\u0026quot; data-contrast=\u0026quot;none\u0026quot;\u0026gt;​\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;ContentControl SCXW76625767 BCX8\u0026quot;\u0026gt;\u0026lt;span class=\u0026quot;ContentControlBoundarySink SCXW76625767 BCX8\u0026quot; lang=\u0026quot;EN-US\u0026quot; data-contrast=\u0026quot;none\u0026quot;\u0026gt;​\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;TextRun SCXW76625767 BCX8\u0026quot; lang=\u0026quot;EN-US\u0026quot; data-contrast=\u0026quot;none\u0026quot;\u0026gt;\u0026lt;span class=\u0026quot;NormalTextRun SCXW76625767 BCX8\u0026quot;\u0026gt;This \u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;NormalTextRun SCXW76625767 BCX8\u0026quot;\u0026gt;individual\u0026amp;nbsp;\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;NormalTextRun SCXW76625767 BCX8\u0026quot;\u0026gt;will need to develop strong relationships with external partners to ensure completion of all aspects of device/drug development and support of Human Factor stud\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;NormalTextRun SCXW76625767 BCX8\u0026quot;\u0026gt;i\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;NormalTextRun SCXW76625767 BCX8\u0026quot;\u0026gt;es\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;NormalTextRun SCXW76625767 BCX8\u0026quot;\u0026gt;\u0026amp;nbsp;from\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;NormalTextRun SCXW76625767 BCX8\u0026quot;\u0026gt;\u0026amp;nbsp;planning\u0026amp;nbsp;\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;NormalTextRun SCXW76625767 BCX8\u0026quot;\u0026gt;to\u0026amp;nbsp;\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;NormalTextRun SCXW76625767 BCX8\u0026quot;\u0026gt;execution. Internal interactions with Business Development, Manufacturing, and Regulatory Affairs provide opportunities to expand knowledge and make an impact on business development and post marketing activities.\u0026lt;/span\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;ContentControlBoundarySink SCXW76625767 BCX8\u0026quot; lang=\u0026quot;EN-US\u0026quot; data-contrast=\u0026quot;none\u0026quot;\u0026gt;​\u0026lt;/span\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;EOP SCXW76625767 BCX8\u0026quot; data-ccp-props=\u0026quot;{}\u0026quot;\u0026gt; Key relationships to this position include Regulatory Affairs, External Partners (Suppliers, CMO and CDMO), Legal, Supply Chain, and Manufacturing.\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;As \u0026lt;span data-teams=\u0026quot;true\u0026quot;\u0026gt;Director, Combination Product Development and Human Factors Engineering\u0026lt;/span\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/span\u0026gt;you will:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Manage and execute the company’s Design Controls and Drug Development Program for drug/device combination product development in accordance with Kaleo’s Quality System and 21 CFR 820.30/ISO 13485\u0026lt;/span\u0026gt;\u0026lt;span data-ccp-props=\u0026quot;{}\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li data-leveltext=\u0026quot;\u0026quot; data-font=\u0026quot;Symbol\u0026quot; data-listid=\u0026quot;4\u0026quot; data-list-defn-props=\u0026quot;{\u0026amp;quot;335551500\u0026amp;quot;:0,\u0026amp;quot;335552541\u0026amp;quot;:1,\u0026amp;quot;335559685\u0026amp;quot;:720,\u0026amp;quot;335559991\u0026amp;quot;:360,\u0026amp;quot;469769226\u0026amp;quot;:\u0026amp;quot;Symbol\u0026amp;quot;,\u0026amp;quot;469769242\u0026amp;quot;:[8226],\u0026amp;quot;469777803\u0026amp;quot;:\u0026amp;quot;left\u0026amp;quot;,\u0026amp;quot;469777804\u0026amp;quot;:\u0026amp;quot;\u0026amp;quot;,\u0026amp;quot;469777815\u0026amp;quot;:\u0026amp;quot;hybridMultilevel\u0026amp;quot;}\u0026quot; data-aria-posinset=\u0026quot;1\u0026quot; data-aria-level=\u0026quot;1\u0026quot;\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;​\u0026lt;/span\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Lead and responsible for human factor engineering activities as per the regulatory guidelines\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li data-leveltext=\u0026quot;\u0026quot; data-font=\u0026quot;Symbol\u0026quot; data-listid=\u0026quot;4\u0026quot; data-list-defn-props=\u0026quot;{\u0026amp;quot;335551500\u0026amp;quot;:0,\u0026amp;quot;335552541\u0026amp;quot;:1,\u0026amp;quot;335559685\u0026amp;quot;:720,\u0026amp;quot;335559991\u0026amp;quot;:360,\u0026amp;quot;469769226\u0026amp;quot;:\u0026amp;quot;Symbol\u0026amp;quot;,\u0026amp;quot;469769242\u0026amp;quot;:[8226],\u0026amp;quot;469777803\u0026amp;quot;:\u0026amp;quot;left\u0026amp;quot;,\u0026amp;quot;469777804\u0026amp;quot;:\u0026amp;quot;\u0026amp;quot;,\u0026amp;quot;469777815\u0026amp;quot;:\u0026amp;quot;hybridMultilevel\u0026amp;quot;}\u0026quot; data-aria-posinset=\u0026quot;1\u0026quot; data-aria-level=\u0026quot;1\u0026quot;\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;​\u0026lt;/span\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Work with design, development and manufacturing partners to ensure program execution for the development of Kaleo’s drug delivery devices stay on timeline and within approved budget\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li data-leveltext=\u0026quot;\u0026quot; data-font=\u0026quot;Symbol\u0026quot; data-listid=\u0026quot;4\u0026quot; data-list-defn-props=\u0026quot;{\u0026amp;quot;335551500\u0026amp;quot;:0,\u0026amp;quot;335552541\u0026amp;quot;:1,\u0026amp;quot;335559685\u0026amp;quot;:720,\u0026amp;quot;335559991\u0026amp;quot;:360,\u0026amp;quot;469769226\u0026amp;quot;:\u0026amp;quot;Symbol\u0026amp;quot;,\u0026amp;quot;469769242\u0026amp;quot;:[8226],\u0026amp;quot;469777803\u0026amp;quot;:\u0026amp;quot;left\u0026amp;quot;,\u0026amp;quot;469777804\u0026amp;quot;:\u0026amp;quot;\u0026amp;quot;,\u0026amp;quot;469777815\u0026amp;quot;:\u0026amp;quot;hybridMultilevel\u0026amp;quot;}\u0026quot; data-aria-posinset=\u0026quot;1\u0026quot; data-aria-level=\u0026quot;1\u0026quot;\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;​\u0026lt;/span\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Execute Risk Management Programs and Analyses in accordance with Kaléo\u0026#39;s Quality System. Utilize Risk Analyses tools including DFMEA, UFMEA and PFMEA in accordance with ISO14971:2019\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li data-leveltext=\u0026quot;\u0026quot; data-font=\u0026quot;Symbol\u0026quot; data-listid=\u0026quot;4\u0026quot; data-list-defn-props=\u0026quot;{\u0026amp;quot;335551500\u0026amp;quot;:0,\u0026amp;quot;335552541\u0026amp;quot;:1,\u0026amp;quot;335559685\u0026amp;quot;:720,\u0026amp;quot;335559991\u0026amp;quot;:360,\u0026amp;quot;469769226\u0026amp;quot;:\u0026amp;quot;Symbol\u0026amp;quot;,\u0026amp;quot;469769242\u0026amp;quot;:[8226],\u0026amp;quot;469777803\u0026amp;quot;:\u0026amp;quot;left\u0026amp;quot;,\u0026amp;quot;469777804\u0026amp;quot;:\u0026amp;quot;\u0026amp;quot;,\u0026amp;quot;469777815\u0026amp;quot;:\u0026amp;quot;hybridMultilevel\u0026amp;quot;}\u0026quot; data-aria-posinset=\u0026quot;1\u0026quot; data-aria-level=\u0026quot;1\u0026quot;\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;​\u0026lt;/span\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Provide leadership for the new products in device design, development, industrialization, stability and pilot clinical activities, execution of design controls and development documentation activities\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li data-leveltext=\u0026quot;\u0026quot; data-font=\u0026quot;Symbol\u0026quot; data-listid=\u0026quot;4\u0026quot; data-list-defn-props=\u0026quot;{\u0026amp;quot;335551500\u0026amp;quot;:0,\u0026amp;quot;335552541\u0026amp;quot;:1,\u0026amp;quot;335559685\u0026amp;quot;:720,\u0026amp;quot;335559991\u0026amp;quot;:360,\u0026amp;quot;469769226\u0026amp;quot;:\u0026amp;quot;Symbol\u0026amp;quot;,\u0026amp;quot;469769242\u0026amp;quot;:[8226],\u0026amp;quot;469777803\u0026amp;quot;:\u0026amp;quot;left\u0026amp;quot;,\u0026amp;quot;469777804\u0026amp;quot;:\u0026amp;quot;\u0026amp;quot;,\u0026amp;quot;469777815\u0026amp;quot;:\u0026amp;quot;hybridMultilevel\u0026amp;quot;}\u0026quot; data-aria-posinset=\u0026quot;1\u0026quot; data-aria-level=\u0026quot;1\u0026quot;\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;​\u0026lt;/span\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Help build Kaleo’s intellectual property portfolio\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li data-leveltext=\u0026quot;\u0026quot; data-font=\u0026quot;Symbol\u0026quot; data-listid=\u0026quot;4\u0026quot; data-list-defn-props=\u0026quot;{\u0026amp;quot;335551500\u0026amp;quot;:0,\u0026amp;quot;335552541\u0026amp;quot;:1,\u0026amp;quot;335559685\u0026amp;quot;:720,\u0026amp;quot;335559991\u0026amp;quot;:360,\u0026amp;quot;469769226\u0026amp;quot;:\u0026amp;quot;Symbol\u0026amp;quot;,\u0026amp;quot;469769242\u0026amp;quot;:[8226],\u0026amp;quot;469777803\u0026amp;quot;:\u0026amp;quot;left\u0026amp;quot;,\u0026amp;quot;469777804\u0026amp;quot;:\u0026amp;quot;\u0026amp;quot;,\u0026amp;quot;469777815\u0026amp;quot;:\u0026amp;quot;hybridMultilevel\u0026amp;quot;}\u0026quot; data-aria-posinset=\u0026quot;1\u0026quot; data-aria-level=\u0026quot;1\u0026quot;\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Manage project and program budgets and timelines effectively\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li data-leveltext=\u0026quot;\u0026quot; data-font=\u0026quot;Symbol\u0026quot; data-listid=\u0026quot;4\u0026quot; data-list-defn-props=\u0026quot;{\u0026amp;quot;335551500\u0026amp;quot;:0,\u0026amp;quot;335552541\u0026amp;quot;:1,\u0026amp;quot;335559685\u0026amp;quot;:720,\u0026amp;quot;335559991\u0026amp;quot;:360,\u0026amp;quot;469769226\u0026amp;quot;:\u0026amp;quot;Symbol\u0026amp;quot;,\u0026amp;quot;469769242\u0026amp;quot;:[8226],\u0026amp;quot;469777803\u0026amp;quot;:\u0026amp;quot;left\u0026amp;quot;,\u0026amp;quot;469777804\u0026amp;quot;:\u0026amp;quot;\u0026amp;quot;,\u0026amp;quot;469777815\u0026amp;quot;:\u0026amp;quot;hybridMultilevel\u0026amp;quot;}\u0026quot; data-aria-posinset=\u0026quot;1\u0026quot; data-aria-level=\u0026quot;1\u0026quot;\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Author and review regulatory submissions (as needed)\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li data-leveltext=\u0026quot;\u0026quot; data-font=\u0026quot;Symbol\u0026quot; data-listid=\u0026quot;4\u0026quot; data-list-defn-props=\u0026quot;{\u0026amp;quot;335551500\u0026amp;quot;:0,\u0026amp;quot;335552541\u0026amp;quot;:1,\u0026amp;quot;335559685\u0026amp;quot;:720,\u0026amp;quot;335559991\u0026amp;quot;:360,\u0026amp;quot;469769226\u0026amp;quot;:\u0026amp;quot;Symbol\u0026amp;quot;,\u0026amp;quot;469769242\u0026amp;quot;:[8226],\u0026amp;quot;469777803\u0026amp;quot;:\u0026amp;quot;left\u0026amp;quot;,\u0026amp;quot;469777804\u0026amp;quot;:\u0026amp;quot;\u0026amp;quot;,\u0026amp;quot;469777815\u0026amp;quot;:\u0026amp;quot;hybridMultilevel\u0026amp;quot;}\u0026quot; data-aria-posinset=\u0026quot;1\u0026quot; data-aria-level=\u0026quot;1\u0026quot;\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;​\u0026lt;/span\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Responsible for reporting progress, risks, and opportunities to senior management on an ongoing basis to ensure good progress on all development portfolio programs\u0026lt;/span\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;​\u0026lt;/span\u0026gt;\u0026lt;span data-ccp-props=\u0026quot;{}\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;A successful\u0026amp;nbsp;\u0026lt;span data-teams=\u0026quot;true\u0026quot;\u0026gt;Director, Combination Product Development and Human Factors Engineering\u0026lt;/span\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/span\u0026gt;will demonstrate:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li data-leveltext=\u0026quot;\u0026quot; data-font=\u0026quot;Symbol\u0026quot; data-listid=\u0026quot;9\u0026quot; data-list-defn-props=\u0026quot;{\u0026amp;quot;335552541\u0026amp;quot;:1,\u0026amp;quot;335559685\u0026amp;quot;:720,\u0026amp;quot;335559991\u0026amp;quot;:360,\u0026amp;quot;469769226\u0026amp;quot;:\u0026amp;quot;Symbol\u0026amp;quot;,\u0026amp;quot;469769242\u0026amp;quot;:[8226],\u0026amp;quot;469777803\u0026amp;quot;:\u0026amp;quot;left\u0026amp;quot;,\u0026amp;quot;469777804\u0026amp;quot;:\u0026amp;quot;\u0026amp;quot;,\u0026amp;quot;469777815\u0026amp;quot;:\u0026amp;quot;hybridMultilevel\u0026amp;quot;}\u0026quot; data-aria-posinset=\u0026quot;1\u0026quot; data-aria-level=\u0026quot;1\u0026quot;\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;​\u0026lt;/span\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;​\u0026lt;/span\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Self-motivated and confident with excellent personnel management skills, organizational skills, analytical abilities, and problem-solving techniques\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li data-leveltext=\u0026quot;\u0026quot; data-font=\u0026quot;Symbol\u0026quot; data-listid=\u0026quot;9\u0026quot; data-list-defn-props=\u0026quot;{\u0026amp;quot;335552541\u0026amp;quot;:1,\u0026amp;quot;335559685\u0026amp;quot;:720,\u0026amp;quot;335559991\u0026amp;quot;:360,\u0026amp;quot;469769226\u0026amp;quot;:\u0026amp;quot;Symbol\u0026amp;quot;,\u0026amp;quot;469769242\u0026amp;quot;:[8226],\u0026amp;quot;469777803\u0026amp;quot;:\u0026amp;quot;left\u0026amp;quot;,\u0026amp;quot;469777804\u0026amp;quot;:\u0026amp;quot;\u0026amp;quot;,\u0026amp;quot;469777815\u0026amp;quot;:\u0026amp;quot;hybridMultilevel\u0026amp;quot;}\u0026quot; data-aria-posinset=\u0026quot;1\u0026quot; data-aria-level=\u0026quot;1\u0026quot;\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Strong technical abilities while being an effective leader\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li data-leveltext=\u0026quot;\u0026quot; data-font=\u0026quot;Symbol\u0026quot; data-listid=\u0026quot;9\u0026quot; data-list-defn-props=\u0026quot;{\u0026amp;quot;335552541\u0026amp;quot;:1,\u0026amp;quot;335559685\u0026amp;quot;:720,\u0026amp;quot;335559991\u0026amp;quot;:360,\u0026amp;quot;469769226\u0026amp;quot;:\u0026amp;quot;Symbol\u0026amp;quot;,\u0026amp;quot;469769242\u0026amp;quot;:[8226],\u0026amp;quot;469777803\u0026amp;quot;:\u0026amp;quot;left\u0026amp;quot;,\u0026amp;quot;469777804\u0026amp;quot;:\u0026amp;quot;\u0026amp;quot;,\u0026amp;quot;469777815\u0026amp;quot;:\u0026amp;quot;hybridMultilevel\u0026amp;quot;}\u0026quot; data-aria-posinset=\u0026quot;1\u0026quot; data-aria-level=\u0026quot;1\u0026quot;\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Must demonstrate initiative, exercise good judgment, and have the ability to achieve results through others\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li data-leveltext=\u0026quot;\u0026quot; data-font=\u0026quot;Symbol\u0026quot; data-listid=\u0026quot;9\u0026quot; data-list-defn-props=\u0026quot;{\u0026amp;quot;335552541\u0026amp;quot;:1,\u0026amp;quot;335559685\u0026amp;quot;:720,\u0026amp;quot;335559991\u0026amp;quot;:360,\u0026amp;quot;469769226\u0026amp;quot;:\u0026amp;quot;Symbol\u0026amp;quot;,\u0026amp;quot;469769242\u0026amp;quot;:[8226],\u0026amp;quot;469777803\u0026amp;quot;:\u0026amp;quot;left\u0026amp;quot;,\u0026amp;quot;469777804\u0026amp;quot;:\u0026amp;quot;\u0026amp;quot;,\u0026amp;quot;469777815\u0026amp;quot;:\u0026amp;quot;hybridMultilevel\u0026amp;quot;}\u0026quot; data-aria-posinset=\u0026quot;1\u0026quot; data-aria-level=\u0026quot;1\u0026quot;\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;​\u0026lt;/span\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Strong analytical skills with the ability to creatively solve complex problems\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li data-leveltext=\u0026quot;\u0026quot; data-font=\u0026quot;Symbol\u0026quot; data-listid=\u0026quot;9\u0026quot; data-list-defn-props=\u0026quot;{\u0026amp;quot;335552541\u0026amp;quot;:1,\u0026amp;quot;335559685\u0026amp;quot;:720,\u0026amp;quot;335559991\u0026amp;quot;:360,\u0026amp;quot;469769226\u0026amp;quot;:\u0026amp;quot;Symbol\u0026amp;quot;,\u0026amp;quot;469769242\u0026amp;quot;:[8226],\u0026amp;quot;469777803\u0026amp;quot;:\u0026amp;quot;left\u0026amp;quot;,\u0026amp;quot;469777804\u0026amp;quot;:\u0026amp;quot;\u0026amp;quot;,\u0026amp;quot;469777815\u0026amp;quot;:\u0026amp;quot;hybridMultilevel\u0026amp;quot;}\u0026quot; data-aria-posinset=\u0026quot;1\u0026quot; data-aria-level=\u0026quot;1\u0026quot;\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;​\u0026lt;/span\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Excellent verbal and written communication skills when interacting with internal stakeholders at all levels of the organization and external partners, facilitating strong working relationships\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li data-leveltext=\u0026quot;\u0026quot; data-font=\u0026quot;Symbol\u0026quot; data-listid=\u0026quot;9\u0026quot; data-list-defn-props=\u0026quot;{\u0026amp;quot;335552541\u0026amp;quot;:1,\u0026amp;quot;335559685\u0026amp;quot;:720,\u0026amp;quot;335559991\u0026amp;quot;:360,\u0026amp;quot;469769226\u0026amp;quot;:\u0026amp;quot;Symbol\u0026amp;quot;,\u0026amp;quot;469769242\u0026amp;quot;:[8226],\u0026amp;quot;469777803\u0026amp;quot;:\u0026amp;quot;left\u0026amp;quot;,\u0026amp;quot;469777804\u0026amp;quot;:\u0026amp;quot;\u0026amp;quot;,\u0026amp;quot;469777815\u0026amp;quot;:\u0026amp;quot;hybridMultilevel\u0026amp;quot;}\u0026quot; data-aria-posinset=\u0026quot;1\u0026quot; data-aria-level=\u0026quot;1\u0026quot;\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Focused attention to detail\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li data-leveltext=\u0026quot;\u0026quot; data-font=\u0026quot;Symbol\u0026quot; data-listid=\u0026quot;9\u0026quot; data-list-defn-props=\u0026quot;{\u0026amp;quot;335552541\u0026amp;quot;:1,\u0026amp;quot;335559685\u0026amp;quot;:720,\u0026amp;quot;335559991\u0026amp;quot;:360,\u0026amp;quot;469769226\u0026amp;quot;:\u0026amp;quot;Symbol\u0026amp;quot;,\u0026amp;quot;469769242\u0026amp;quot;:[8226],\u0026amp;quot;469777803\u0026amp;quot;:\u0026amp;quot;left\u0026amp;quot;,\u0026amp;quot;469777804\u0026amp;quot;:\u0026amp;quot;\u0026amp;quot;,\u0026amp;quot;469777815\u0026amp;quot;:\u0026amp;quot;hybridMultilevel\u0026amp;quot;}\u0026quot; data-aria-posinset=\u0026quot;1\u0026quot; data-aria-level=\u0026quot;1\u0026quot;\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;​\u0026lt;/span\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Ability to work collaboratively and cross-functionally when opportunity arises while holding the team to high standards of excellence\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li data-leveltext=\u0026quot;\u0026quot; data-font=\u0026quot;Symbol\u0026quot; data-listid=\u0026quot;9\u0026quot; data-list-defn-props=\u0026quot;{\u0026amp;quot;335552541\u0026amp;quot;:1,\u0026amp;quot;335559685\u0026amp;quot;:720,\u0026amp;quot;335559991\u0026amp;quot;:360,\u0026amp;quot;469769226\u0026amp;quot;:\u0026amp;quot;Symbol\u0026amp;quot;,\u0026amp;quot;469769242\u0026amp;quot;:[8226],\u0026amp;quot;469777803\u0026amp;quot;:\u0026amp;quot;left\u0026amp;quot;,\u0026amp;quot;469777804\u0026amp;quot;:\u0026amp;quot;\u0026amp;quot;,\u0026amp;quot;469777815\u0026amp;quot;:\u0026amp;quot;hybridMultilevel\u0026amp;quot;}\u0026quot; data-aria-posinset=\u0026quot;1\u0026quot; data-aria-level=\u0026quot;1\u0026quot;\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Display a tenacity to move major initiatives forward with a focused effort and clear set of business goals\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li data-leveltext=\u0026quot;\u0026quot; data-font=\u0026quot;Symbol\u0026quot; data-listid=\u0026quot;9\u0026quot; data-list-defn-props=\u0026quot;{\u0026amp;quot;335552541\u0026amp;quot;:1,\u0026amp;quot;335559685\u0026amp;quot;:720,\u0026amp;quot;335559991\u0026amp;quot;:360,\u0026amp;quot;469769226\u0026amp;quot;:\u0026amp;quot;Symbol\u0026amp;quot;,\u0026amp;quot;469769242\u0026amp;quot;:[8226],\u0026amp;quot;469777803\u0026amp;quot;:\u0026amp;quot;left\u0026amp;quot;,\u0026amp;quot;469777804\u0026amp;quot;:\u0026amp;quot;\u0026amp;quot;,\u0026amp;quot;469777815\u0026amp;quot;:\u0026amp;quot;hybridMultilevel\u0026amp;quot;}\u0026quot; data-aria-posinset=\u0026quot;1\u0026quot; data-aria-level=\u0026quot;1\u0026quot;\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;​\u0026lt;/span\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Adept at integrating input from various functional areas and bringing people together to achieve results\u0026lt;/span\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;​\u0026lt;/span\u0026gt;\u0026lt;span data-ccp-props=\u0026quot;{}\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;To be considered for this position, you must have:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li data-leveltext=\u0026quot;\u0026quot; data-font=\u0026quot;Symbol\u0026quot; data-listid=\u0026quot;5\u0026quot; data-list-defn-props=\u0026quot;{\u0026amp;quot;335551500\u0026amp;quot;:0,\u0026amp;quot;335552541\u0026amp;quot;:1,\u0026amp;quot;335559685\u0026amp;quot;:720,\u0026amp;quot;335559991\u0026amp;quot;:360,\u0026amp;quot;469769226\u0026amp;quot;:\u0026amp;quot;Symbol\u0026amp;quot;,\u0026amp;quot;469769242\u0026amp;quot;:[8226],\u0026amp;quot;469777803\u0026amp;quot;:\u0026amp;quot;left\u0026amp;quot;,\u0026amp;quot;469777804\u0026amp;quot;:\u0026amp;quot;\u0026amp;quot;,\u0026amp;quot;469777815\u0026amp;quot;:\u0026amp;quot;hybridMultilevel\u0026amp;quot;}\u0026quot; data-aria-posinset=\u0026quot;1\u0026quot; data-aria-level=\u0026quot;1\u0026quot;\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Bachelors, Masters, or PhD in a technical field related to Product Development or Industrialization (Biomedical Engineering, Mechanical Engineering, Material engineering, Systems Engineering preferred)\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li data-leveltext=\u0026quot;\u0026quot; data-font=\u0026quot;Symbol\u0026quot; data-listid=\u0026quot;5\u0026quot; data-list-defn-props=\u0026quot;{\u0026amp;quot;335551500\u0026amp;quot;:0,\u0026amp;quot;335552541\u0026amp;quot;:1,\u0026amp;quot;335559685\u0026amp;quot;:720,\u0026amp;quot;335559991\u0026amp;quot;:360,\u0026amp;quot;469769226\u0026amp;quot;:\u0026amp;quot;Symbol\u0026amp;quot;,\u0026amp;quot;469769242\u0026amp;quot;:[8226],\u0026amp;quot;469777803\u0026amp;quot;:\u0026amp;quot;left\u0026amp;quot;,\u0026amp;quot;469777804\u0026amp;quot;:\u0026amp;quot;\u0026amp;quot;,\u0026amp;quot;469777815\u0026amp;quot;:\u0026amp;quot;hybridMultilevel\u0026amp;quot;}\u0026quot; data-aria-posinset=\u0026quot;1\u0026quot; data-aria-level=\u0026quot;1\u0026quot;\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Patient centric drug/device combination product development experience\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li data-leveltext=\u0026quot;\u0026quot; data-font=\u0026quot;Symbol\u0026quot; data-listid=\u0026quot;5\u0026quot; data-list-defn-props=\u0026quot;{\u0026amp;quot;335551500\u0026amp;quot;:0,\u0026amp;quot;335552541\u0026amp;quot;:1,\u0026amp;quot;335559685\u0026amp;quot;:720,\u0026amp;quot;335559991\u0026amp;quot;:360,\u0026amp;quot;469769226\u0026amp;quot;:\u0026amp;quot;Symbol\u0026amp;quot;,\u0026amp;quot;469769242\u0026amp;quot;:[8226],\u0026amp;quot;469777803\u0026amp;quot;:\u0026amp;quot;left\u0026amp;quot;,\u0026amp;quot;469777804\u0026amp;quot;:\u0026amp;quot;\u0026amp;quot;,\u0026amp;quot;469777815\u0026amp;quot;:\u0026amp;quot;hybridMultilevel\u0026amp;quot;}\u0026quot; data-aria-posinset=\u0026quot;1\u0026quot; data-aria-level=\u0026quot;1\u0026quot;\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;​\u0026lt;/span\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Minimum 10+ years of medical device development experience, with experience in managing external CMO’s\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li data-leveltext=\u0026quot;\u0026quot; data-font=\u0026quot;Symbol\u0026quot; data-listid=\u0026quot;5\u0026quot; data-list-defn-props=\u0026quot;{\u0026amp;quot;335551500\u0026amp;quot;:0,\u0026amp;quot;335552541\u0026amp;quot;:1,\u0026amp;quot;335559685\u0026amp;quot;:720,\u0026amp;quot;335559991\u0026amp;quot;:360,\u0026amp;quot;469769226\u0026amp;quot;:\u0026amp;quot;Symbol\u0026amp;quot;,\u0026amp;quot;469769242\u0026amp;quot;:[8226],\u0026amp;quot;469777803\u0026amp;quot;:\u0026amp;quot;left\u0026amp;quot;,\u0026amp;quot;469777804\u0026amp;quot;:\u0026amp;quot;\u0026amp;quot;,\u0026amp;quot;469777815\u0026amp;quot;:\u0026amp;quot;hybridMultilevel\u0026amp;quot;}\u0026quot; data-aria-posinset=\u0026quot;1\u0026quot; data-aria-level=\u0026quot;1\u0026quot;\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;​\u0026lt;/span\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Experience in design controls, risk management and ISO 13485 \u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li data-leveltext=\u0026quot;\u0026quot; data-font=\u0026quot;Symbol\u0026quot; data-listid=\u0026quot;5\u0026quot; data-list-defn-props=\u0026quot;{\u0026amp;quot;335551500\u0026amp;quot;:0,\u0026amp;quot;335552541\u0026amp;quot;:1,\u0026amp;quot;335559685\u0026amp;quot;:720,\u0026amp;quot;335559991\u0026amp;quot;:360,\u0026amp;quot;469769226\u0026amp;quot;:\u0026amp;quot;Symbol\u0026amp;quot;,\u0026amp;quot;469769242\u0026amp;quot;:[8226],\u0026amp;quot;469777803\u0026amp;quot;:\u0026amp;quot;left\u0026amp;quot;,\u0026amp;quot;469777804\u0026amp;quot;:\u0026amp;quot;\u0026amp;quot;,\u0026amp;quot;469777815\u0026amp;quot;:\u0026amp;quot;hybridMultilevel\u0026amp;quot;}\u0026quot; data-aria-posinset=\u0026quot;1\u0026quot; data-aria-level=\u0026quot;1\u0026quot;\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Minimum 5+ years of managing human factor engineering studies (formative and summative) \u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;li data-leveltext=\u0026quot;\u0026quot; data-font=\u0026quot;Symbol\u0026quot; data-listid=\u0026quot;5\u0026quot; data-list-defn-props=\u0026quot;{\u0026amp;quot;335551500\u0026amp;quot;:0,\u0026amp;quot;335552541\u0026amp;quot;:1,\u0026amp;quot;335559685\u0026amp;quot;:720,\u0026amp;quot;335559991\u0026amp;quot;:360,\u0026amp;quot;469769226\u0026amp;quot;:\u0026amp;quot;Symbol\u0026amp;quot;,\u0026amp;quot;469769242\u0026amp;quot;:[8226],\u0026amp;quot;469777803\u0026amp;quot;:\u0026amp;quot;left\u0026amp;quot;,\u0026amp;quot;469777804\u0026amp;quot;:\u0026amp;quot;\u0026amp;quot;,\u0026amp;quot;469777815\u0026amp;quot;:\u0026amp;quot;hybridMultilevel\u0026amp;quot;}\u0026quot; data-aria-posinset=\u0026quot;1\u0026quot; data-aria-level=\u0026quot;1\u0026quot;\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Demonstrated record of accomplishments preferred (e.g., issued US patents, device concept to launch, approved drug/device combination products)\u0026lt;/span\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;​\u0026lt;/span\u0026gt;\u0026lt;span data-ccp-props=\u0026quot;{}\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/span\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;","departments":[{"id":4024702003,"name":"Development and Industrialization","child_ids":[],"parent_id":null}],"offices":[{"id":4015692003,"name":"Corporate Remote","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kaleo/jobs/5222715003","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":4641858003,"location":{"name":"Nationwide - United States"},"metadata":null,"id":5222715003,"updated_at":"2024-11-18T14:40:24-05:00","requisition_id":"127","title":"Inquire About Future Corporate Openings","company_name":"Kaléo","first_published":"2022-07-14T11:32:22-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Interested in Kaléo, but don’t see a position that is a match for your interests or location right now? \u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;If you would like to join a team of people who are purposefully driven to make a difference, we invite you to submit your resume for future openings in our corporate organization.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;We are always looking for talented individuals for our teams in:\u0026lt;/p\u0026gt;\n\u0026lt;p style=\u0026quot;line-height: 1;\u0026quot;\u0026gt;Market Access\u0026lt;/p\u0026gt;\n\u0026lt;p style=\u0026quot;line-height: 1;\u0026quot;\u0026gt;Compliance\u0026lt;/p\u0026gt;\n\u0026lt;p style=\u0026quot;line-height: 1;\u0026quot;\u0026gt;Marketing\u0026lt;/p\u0026gt;\n\u0026lt;p style=\u0026quot;line-height: 1;\u0026quot;\u0026gt;Legal\u0026lt;/p\u0026gt;\n\u0026lt;p style=\u0026quot;line-height: 1;\u0026quot;\u0026gt;Regulatory Affairs\u0026lt;/p\u0026gt;\n\u0026lt;p style=\u0026quot;line-height: 1;\u0026quot;\u0026gt;Quality Assurance\u0026lt;/p\u0026gt;\n\u0026lt;p style=\u0026quot;line-height: 1;\u0026quot;\u0026gt;Manufacturing Engineering\u0026lt;/p\u0026gt;\n\u0026lt;p style=\u0026quot;line-height: 1;\u0026quot;\u0026gt;Medical Affairs\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;And more! Please send us your information, and we’ll reach out the next time we have an opening that could be a match.\u0026lt;/p\u0026gt;","departments":[{"id":4050508003,"name":"Corporate General","child_ids":[],"parent_id":null}],"offices":[{"id":4015692003,"name":"Corporate Remote","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kaleo/jobs/7776025003","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":5782521003,"location":{"name":"Remote"},"metadata":null,"id":7776025003,"updated_at":"2026-06-17T09:52:22-04:00","requisition_id":"235","title":"Systems Administrator, Electronic GxP Systems ","company_name":"Kaléo","first_published":"2026-06-17T09:52:22-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;This is a remote opportunity with occasional travel, estimated at less than 10%.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kaléo is a global leader in drug‑delivery device technology and auto‑injector innovation, providing millions of patients, government partners, and emergency responders with security and peace of mind.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The \u0026lt;strong\u0026gt;Systems Administrator, Electronic GxP Systems\u0026lt;/strong\u0026gt; is a critical contributor to a high-performing Quality Assurance organization focused on building reliable, inspection-ready systems that support compliant execution at-scale. This role ensures that electronic GxP and GxP-supporting systems remain validated, traceable, and defensible, forming a stable digital foundation for quality oversight and decision-making.\u0026amp;nbsp; The position serves as the hands-on technical authority for electronic quality systems, including MasterControl and other systems \u0026amp;amp; applications, and ensures these systems remain in a state of control throughout their lifecycle.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The ideal candidate is a hands-on technical expert with deep experience in validated systems, data integrity, and electronic quality tools, who thrives in execution and takes ownership of keeping systems in a continuous state of control. Operating in a regulated pharmaceutical and combination-product environment, this role enables teams to focus on risk, performance, and improvement – confident that the systems underpinning the work are sound.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;As Systems Administrator, Electronic GxP Systems you will:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Serve as the system administrator and execution owner for all electronic GxP systems and GxP supporting applications used to create, manage, store, or report regulated quality data\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maintain a complete and current inventory or electronic GxP and GxP-supporting systems, including system purpose, GxP impact, validation status, and system ownership\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure all applicable systems are appropriately classified for GxP impact, validated and maintained in a validated state, traceable to intended use and regulatory requirements, and defensible during audits and inspections\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as the primary or backup system administrator for multiple electronic systems platforms, for example: platforms and systems supporting document control, training, change control, deviations, investigations, CAPA, audit, customer complaint workflows, electronic batch records, external submissions, and device history file(s)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Configure, maintain, and execute system workflows and forms, metadata and taxonomy structures, user roles, permissions, and security models\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Controlled system changes in accordance with validation requirements\u0026amp;nbsp;\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide quality system execution oversight for GxP-supporting applications that interface with or support GxP activities (e.g. reporting tools, repositories, workflow platforms, and validated interfaces)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner with Information Technology and systems owners to ensure appropriate approach and documentation, controlled access and data protection(s), and change management aligned with GxP risk profile\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Execute and support system validation activities across the system lifecycle, including validation planning and impact assessments, IQ/OQ/PQ documentation and test execution, and validated evidence maintenance and archival\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure all system changes, upgrades, and enhancements follow approved change control and validation procedures\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maintain inspection-ready validation documentation at all times.\u0026amp;nbsp;\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop, maintain, and execute system-level reports while ensuring system data is accurate, reliable, attributable, legible, contemporaneous, original, and complete (ALCOA+)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as a system subject matter expert (SME), including back-room inspection support and direct system demonstrations as required\u0026amp;nbsp;\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide day-to-day technical support for electronic GxP systems, including issue triage, troubleshooting, and resolution while evaluating new system features and tools to provide recommendations based on compliance and operational impact\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Participate in industry forums, user groups, and training related to electronic GxP systems and validation best practices\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;A successful Systems Administrator, Electronic GxP Systems will demonstrate:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Strong working knowledge of applicable regulations and standards related to electronic GxP systems, including 21 CFR Parts 11, 210, 211, 820/QMSR, ISO 13485 and applicable ICH guidance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated expertise in data integrity principles (ALCOA+) and their application with electronic systems\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to assess GxP impact and apply appropriate controls for GxP-supporting systems\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;High technical judgement in executing system changes while maintaining compliance and inspection readiness\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent analytical and problem-solving skills, with the ability to troubleshoot system issues and implement effective, compliant solutions\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong written and verbal communication skills, particularly when explaining system functionality and compliance concepts to non-technical users\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to manage multiple system activities and priorities independently while maintaining accuracy, traceability, and quality\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Detail-oriented, execution-focused mindset with a demonstrated record of reliable follow-through\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Comfortable operating as an individual contributor in a regulated environment with clear accountability for system execution.\u0026amp;nbsp;\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;To be considered for the position, you must have:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s or Master\u0026#39;s degree in a scientific, technical, or information systems-related discipline (e.g., life sciences, engineering, computer science, or equivalent experience)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Minimum 6+ years of experience supporting Quality Assurance systems in a regulated pharmaceutical, biotechnology, medical device, or combination product environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated hands-on experience administering electronic GxP systems, such as MasterControl, Veeva, TrackWise, Documentum, or equivalent quality systems\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven experience supporting validated system lifecycles, including system implementation, configuration, change control, upgrades, and decommissioning\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Working knowledge of GxP systems validation principles, including risk-based validation, testing execution, and maintenance of validated state\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong proficiency with Microsoft 365 and system reporting tools\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience supporting internal audits and regulatory inspections as a system SME\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to travel occasionally (up to ~10%) as required for system support or inspections\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;","departments":[{"id":4024298003,"name":"Supply Chain","child_ids":[],"parent_id":null}],"offices":[{"id":4015692003,"name":"Corporate Remote","location":null,"child_ids":[],"parent_id":null}]}],"meta":{"total":4}}