Sr Program Manager L2
Job in
Bothell, King County, Washington, 98011, USA
Listed on 2026-07-19
Listing for:
Pacer Group
Contract
position Listed on 2026-07-19
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering
Job Description & How to Apply Below
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
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