Job Description

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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