Project Manager - Medical Devices
Full-time
Mobile Apps US
Project Manager – Medical Devices
Location: Bothell, WA – Onsite
Experience: 12+ years
Key Responsibilities:
- Serve as the onsite customer-facing Project Manager and primary point of contact.
- Manage project plans, milestones, resources, scope, dependencies, and deliverables.
- Maintain Smartsheet dashboards, RAID logs, action trackers, and decision logs .
- Lead daily coordination, weekly status meetings, governance reviews, and executive reporting.
- Track risks, issues, KPIs, acceptance criteria, and project closure.
- Coordinate engineering, Quality, Regulatory, Supplier Quality, PMS, and documentation teams.
- Manage onsite/offshore resources, change control, backlog readiness, and customer communication.
Required Skills:
- 12+ years of Project/Program Management experience.
- Medical device or other regulated industry experience.
- Customer-facing onsite/offshore delivery experience.
- Experience with fixed-price or milestone-based programs.
- Knowledge of medical-device design controls, DHF, FMEA, V&V, and audit readiness .
- Working knowledge of ISO 13485, ISO 14971, FDA QSR, and EU MDR .
- Strong stakeholder management, communication, negotiation, and problem-solving skills.
Vacancy posted 3 days ago
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