SR PROGRAM MANAGER L2(CONTRACT)

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