Technical Project Manager (MLD)

Job Title: Technical Project Manager (MLD)

Location : Bothell, WA, USA

Duration:: Temp OR FTE

Interview: Virtual

Role and Responsibilities:

• Manage Project as $B!G(Js onsite single point of contact for program management, functional leads, SMEs, and Steering Committee members.
• Develop and maintain integrated work-package, milestone, resource, and product-wave plans aligned with the customer-owned Integrated Master Schedule.
• Manage scope, priorities, dependencies, deliverables, acceptance criteria, and Definition of Done across multidisciplinary workstreams.
• Maintain Smartsheet dashboards, milestone trackers, RAID registers, decision logs, action trackers, and completion forecasts.
• Lead daily coordination, weekly status reviews, monthly governance meetings, and executive-level reporting.
• Proactively identify and escalate risks involving documentation, system access, SME reviews, supplier evidence, V&V records, resources, and schedule.
• Coordinate cross-functional reviews, comment resolution, controlled-document release, milestone acceptance, and product closure.
• Monitor delivery KPIs, including on-time delivery, first-pass acceptance, traceability completion, review turnaround, and action closure.
• Manage onsite-offshore coordination, resource capacity, backlog readiness, knowledge transfer, change control, and customer communication.

Education & Experience:

• Bachelor$B!G(Js degree in Engineering, Life Sciences, or a related discipline.
• At least 12 years of project or program management experience, including experience in medical devices or another regulated industry.
• Proven experience managing customer-facing onsite and offshore delivery models.
• Experience of delivering fixed-price, milestone-based, or outcome-based programs.
• Experience leading multidisciplinary engineering, Quality, Regulatory, Supplier Quality, PMS, and documentation teams.
• Strong knowledge of project planning, milestone management, governance, RAID management, scope control, and executive reporting.
• Understanding of medical-device design controls, DHF remediation, risk management, FMEAs, V&V documentation, and audit readiness.
• Working knowledge of ISO 13485, ISO 14971, FDA quality-system requirements, and EU MDR principles.
• Strong stakeholder management, facilitation, negotiation, communication, and problem-solving skills.