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SR PROGRAM MANAGER L2(CONTRACT)

Pacer Group

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 resolution
  • V&V: Approved protocols, executed testing, validation report, defect closure ? agreed thresholds
  • Design Transfer: Transfer plan, DHF readiness, manufacturing handoff documentation
  • Quality/Regulatory: Updated risk files (ISO 14971), design control evidence, submission support artifacts
  • Launch Readiness: Readiness checklist, status reporting, stakeholder alignment

Responsibilities:

  • Lead program execution, schedule, risks, and cross-functional alignment
  • Drive HW/SW/cloud/mobile integration and dependency management
  • Oversee system-level V&V, defect triage, and traceability
  • Ensure compliance with FDA 820, ISO 13485, and design controls
  • Coordinate with R&D, QA/RA, Manufacturing, and vendors; escalate risks and drive decisions

Timeline & Milestones (Indicative):

  • Integration: System integration complete
  • Verification: V&V execution and defect resolution
  • Validation & Transfer: Validation complete; DHF ready; design transfer initiated
  • Launch Readiness: Manufacturing and regulatory readiness achieved

Stakeholders:

  • R&D (HW, software, cloud, mobile)
  • QA/RA
  • Manufacturing
  • Supply Chain
  • External Vendors
  • Executive Leadership

Required 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 14971
  • Strong background in V&V, integration, and defect management
  • Proven cross-functional leadership and delivery in fast-paced environments
  • Preferred: SaMD, connected devices, cybersecurity, usability, global launches
Pacer Group
Vacancy posted 3 days ago
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