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Senior Program Manager – Medical Devices
Bothell, WA, US · On-site · Full-time
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About the role
Program ManagementStakeholder ManagementRisk Management
 
Role & Responsibilities:
- Serve as the onsite point of contact for program management, functional leads, SMEs, and stakeholders.
- Develop and manage project plans, milestones, resources, deliverables, and schedules.
- Track project progress, risks, dependencies, action items, and deliverables using Smartsheet.
- Lead daily coordination meetings, weekly status reviews, and monthly governance meetings.
- Manage scope, priorities, change control, and milestone acceptance.
- Coordinate onsite and offshore teams, resource planning, and knowledge transfer.
- Monitor project KPIs, delivery timelines, quality, and documentation.
- Ensure timely escalation and resolution of project risks and issues.
Requirements:
- Bachelor's degree in Engineering, Life Sciences, or a related field.
- 12+ years of project/program management experience.
- Experience in medical devices or other regulated industries.
- Proven experience managing onsite and offshore delivery teams.
- Experience with fixed-price and milestone-based projects.
- Knowledge of medical device design controls, DHF, FMEA, risk management, and V&V documentation.
- Familiarity with ISO 13485, ISO 14971, FDA quality requirements, and EU MDR.
- Strong leadership, stakeholder management, communication, and problem-solving skills.
All your information will be kept confidential according to EEO guidelines.