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.

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