{"schemaVersion":"jobsearcher.job.v1","id":"09cdb5d669264ab7789436f4","url":"https://jobsearcher.com/jobs/09cdb5d669264ab7789436f4","canonicalUrl":"https://jobsearcher.com/jobs/09cdb5d669264ab7789436f4","title":"SR PROGRAM MANAGER L2(CONTRACT)","description":"Senior Program Manager Medical Device R&D (Contract)Job Title: Senior Program Manager Medical Device R&D (Contract)Location: Bothell, WA (Onsite)Objective & Scope: Lead late-stage R&D for a medical device program integrating hardware, software, cloud, and mobile systems. Focus on system integration, verification & validation (V&V), design transfer, and launch readiness in compliance with FDA 21 CFR Part 820 and ISO 13485.Key Deliverables:System Integration: Integrated system milestones; end-to-end test plan; defect tracking and resolutionV&V: Approved protocols, executed testing, validation report, defect closure ? agreed thresholdsDesign Transfer: Transfer plan, DHF readiness, manufacturing handoff documentationQuality/Regulatory: Updated risk files (ISO 14971), design control evidence, submission support artifactsLaunch Readiness: Readiness checklist, status reporting, stakeholder alignmentResponsibilities:Lead program execution, schedule, risks, and cross-functional alignmentDrive HW/SW/cloud/mobile integration and dependency managementOversee system-level V&V, defect triage, and traceabilityEnsure compliance with FDA 820, ISO 13485, and design controlsCoordinate with R&D, QA/RA, Manufacturing, and vendors; escalate risks and drive decisionsTimeline & Milestones (Indicative):Integration: System integration completeVerification: V&V execution and defect resolutionValidation & Transfer: Validation complete; DHF ready; design transfer initiatedLaunch Readiness: Manufacturing and regulatory readiness achievedStakeholders:R&D (HW, software, cloud, mobile)QA/RAManufacturingSupply ChainExternal VendorsExecutive LeadershipRequired Expertise:8+ years in medical device program management (late-stage focus)Experience with integrated systems (HW/SW/cloud/mobile)Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971Strong background in V&V, integration, and defect managementProven cross-functional leadership and delivery in fast-paced environmentsPreferred: SaMD, connected devices, cybersecurity, usability, global launches","company":"Pacer Group","rawCompany":"pacer group","city":"Bothell","state":"WA","isRemote":false,"isActive":false,"createdAt":"2026-08-17T04:07:52.495Z","occupations":[{"code":"13-1082.00","title":"Project Management Specialists","slug":"project-management-specialists"},{"code":"11-9111.00","title":"Medical and Health Services Managers","slug":"medical-and-health-services-managers"},{"code":"11-9151.00","title":"Social and Community Service Managers","slug":"social-and-community-service-managers"}],"industries":[{"code":"541715","title":"Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)","slug":"research-and-development-in-the-physical-engineering-and-life-sciences-except-nanotechnology-and-biotechnology"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"541512","title":"Computer Systems Design Services","slug":"computer-systems-design-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"SR PROGRAM MANAGER L2(CONTRACT)","description":"Senior Program Manager Medical Device R&D (Contract)Job Title: Senior Program Manager Medical Device R&D (Contract)Location: Bothell, WA (Onsite)Objective & Scope: Lead late-stage R&D for a medical device program integrating hardware, software, cloud, and mobile systems. Focus on system integration, verification & validation (V&V), design transfer, and launch readiness in compliance with FDA 21 CFR Part 820 and ISO 13485.Key Deliverables:System Integration: Integrated system milestones; end-to-end test plan; defect tracking and resolutionV&V: Approved protocols, executed testing, validation report, defect closure ? agreed thresholdsDesign Transfer: Transfer plan, DHF readiness, manufacturing handoff documentationQuality/Regulatory: Updated risk files (ISO 14971), design control evidence, submission support artifactsLaunch Readiness: Readiness checklist, status reporting, stakeholder alignmentResponsibilities:Lead program execution, schedule, risks, and cross-functional alignmentDrive HW/SW/cloud/mobile integration and dependency managementOversee system-level V&V, defect triage, and traceabilityEnsure compliance with FDA 820, ISO 13485, and design controlsCoordinate with R&D, QA/RA, Manufacturing, and vendors; escalate risks and drive decisionsTimeline & Milestones (Indicative):Integration: System integration completeVerification: V&V execution and defect resolutionValidation & Transfer: Validation complete; DHF ready; design transfer initiatedLaunch Readiness: Manufacturing and regulatory readiness achievedStakeholders:R&D (HW, software, cloud, mobile)QA/RAManufacturingSupply ChainExternal VendorsExecutive LeadershipRequired Expertise:8+ years in medical device program management (late-stage focus)Experience with integrated systems (HW/SW/cloud/mobile)Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971Strong background in V&V, integration, and defect managementProven cross-functional leadership and delivery in fast-paced environmentsPreferred: SaMD, connected devices, cybersecurity, usability, global launches","datePosted":"2026-08-17T04:07:52.495Z","dateModified":"2026-08-17T04:07:52.495Z","hiringOrganization":{"@type":"Organization","name":"Pacer Group","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Bothell","addressRegion":"WA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"09cdb5d669264ab7789436f4"},"url":"https://jobsearcher.com/jobs/09cdb5d669264ab7789436f4"}}