Technical Project Manager (Medical Device)

Job Description

Role: Technical Project Manager (MLD)

\n

Location - Bothell, WA, USA

\n

Duration – Temp OR FTE.

\n

\n

Role and Responsibilities:

\n

\n
1. Manage Project as onsite single point of contact for program management, functional leads, SMEs, and Steering Committee members.

\n

2. Develop and maintain integrated work-package, milestone, resource, and product-wave plans aligned with the customer-owned Integrated Master Schedule.

\n

3. Manage scope, priorities, dependencies, deliverables, acceptance criteria, and Definition of Done across multidisciplinary workstreams.

\n

4. Maintain Smartsheet dashboards, milestone trackers, RAID registers, decision logs, action trackers, and completion forecasts.

\n

5. Lead daily coordination, weekly status reviews, monthly governance meetings, and executive-level reporting.

\n

6. Proactively identify and escalate risks involving documentation, system access, SME reviews, supplier evidence, V&V records, resources, and schedule.

\n

7. Coordinate cross-functional reviews, comment resolution, controlled-document release, milestone acceptance, and product closure.

\n

8. Monitor delivery KPIs, including on-time delivery, first-pass acceptance, traceability completion, review turnaround, and action closure.

\n

9. Manage onsite-offshore coordination, resource capacity, backlog readiness, knowledge transfer, change control, and customer communication.

\n

10. Proven leadership experience in managing cross-functional and multidisciplinary teams, including Engineering, Quality, Regulatory Affairs, Supplier Quality, and Post-Market Surveillance.

\n

11. Preferred educational background: Bachelor's or Master's degree in Mechanical Engineering or Electro-Mechanical Engineering.

\n

12. Project Management experience in MLD Projects and Remediation projects is highly desirable and will be considered a strong advantage.

\n

\n

\n

Education & Experience:

\n

\n
1. Bachelor in degree in Engineering, Life Sciences, or a related discipline.

\n

2. At least 12 years of project or program management experience, including experience in medical devices or another regulated industry.

\n

3. Proven experience managing customer-facing onsite and offshore delivery models.

\n

4. Experience of delivering fixed-price, milestone-based, or outcome-based programs.

\n

5. Experience leading multidisciplinary engineering, Quality, Regulatory, Supplier Quality, PMS, and documentation teams.

\n

6. Strong knowledge of project planning, milestone management, governance, RAID management, scope control, and executive reporting.

\n

7. Understanding of medical-device design controls, DHF remediation, risk management, FMEAs, V&V documentation, and audit readiness.

\n

8. Working knowledge of ISO 13485, ISO 14971, FDA quality-system requirements, and EU MDR principles.

\n

9. Strong stakeholder management, facilitation, negotiation, communication, and problem-solving skills

\n

\n