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
$132.98k - $199.47k
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