Job Description

Job Description

Project Manager – Medical Devices

Location: Bothell, WA – Onsite

Experience: 12+ years

Key Responsibilities:

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• Serve as the onsite customer-facing Project Manager and primary point of contact.
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• Manage project plans, milestones, resources, scope, dependencies, and deliverables.
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• Maintain Smartsheet dashboards, RAID logs, action trackers, and decision logs .
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• Lead daily coordination, weekly status meetings, governance reviews, and executive reporting.
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• Track risks, issues, KPIs, acceptance criteria, and project closure.
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• Coordinate engineering, Quality, Regulatory, Supplier Quality, PMS, and documentation teams.
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• Manage onsite/offshore resources, change control, backlog readiness, and customer communication.
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Required Skills:

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• 12+ years of Project/Program Management experience.
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• Medical device or other regulated industry experience.
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• Customer-facing onsite/offshore delivery experience.
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• Experience with fixed-price or milestone-based programs.
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• Knowledge of medical-device design controls, DHF, FMEA, V&V, and audit readiness .
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• Working knowledge of ISO 13485, ISO 14971, FDA QSR, and EU MDR .
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• Strong stakeholder management, communication, negotiation, and problem-solving skills.
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