Senior Program Manager - Medical Devices (Consulting)

Senior Program Manager - Medical Devices (Consulting) Cambridge Design Partnership Raleigh, NC Job Details 11 hours ago Qualifications Developing medical devices Project reporting Product design project leadership Managing medical device teams Medical device validation Project development phase management New product introduction engineering projects Project engineering Customer relationship building Managing healthcare project budgets Business development within consulting Medical device testing Project change management Client relationship development Global team management Collaboration with product development teams Managing engineering teams Quality risk management Engineering project budget management Project management in healthcare Client management Design engineering Leading team collaboration initiatives Collaboration with manufacturing teams Design controls Biomedical regulatory compliance Management reporting Managing projects Budget management in healthcare Manufacturing Full Job Description Join CDP's US Healthcare & MedTech team to lead multi‑phase programs (often >$1M) for life sciences , drug‑delivery, and medical‑device clients. You'll coordinate multidisciplinary teams across Raleigh and Cambridge (UK), manage complex stakeholder landscapes, and ensure delivery excellence under FDA design controls/QMSR (aligned to

ISO 13485

) and

ISO 14971

risk management. What you'll do Lead early-stage project definition, including shaping technical approaches, defining scope, and aligning with client objectives Own end‑to‑end delivery for one or more device development programs -from concept through verification/validation to design transfer, balancing scope, schedule, budget, risks, and issues. Run program governance and phase gates; manage inter‑project dependencies and shared resources across multiple workstreams. Develop structured project plans covering timelines, resourcing, risks, and dependencies across multidisciplinary teams Translate ambiguous client needs into clear Statements of Work, workstreams, and deliverables Build trusted client relationships (10-20% client‑facing); run clear communications and status; present to executive stakeholders.

Drive commercial health:

author SOWs/proposals, manage MSAs and change orders, and support BD on account opportunities.

Ensure regulatory alignment:

FDA QMSR/ISO

13485 and

ISO 14971

integration; maintain traceability from user needs to design inputs/outputs, V&V, and risk controls. Coordinate distributed teams in the US/UK and external partners/CMOs; assure hand-offs into pilot manufacture/transfer. Work pattern & travel Raleigh‑based hybrid (on‑site 3 days/week) with collaboration across US and UK time zones; ~10-20% travel (domestic and to the UK). Requirements 8+ years leading medical‑device development with responsibility for >$1M budgets and multi‑phase delivery; success across late‑stage D&V and design transfer. Strong client‑facing leadership in consulting or OEM; adept with scope/change control, stakeholder management, and crisp executive reporting. Demonstrated command of FDA design controls under QMSR (ISO 13485‑aligned) and

ISO 14971

risk management; human factors/usability (IEC 62366) a plus. Experience leading distributed, cross‑functional teams (HF, QA/RA, ME/EE, SW, manufacturing). Strong experience in scoping and structuring complex product development programs from early concept through to transfer Ability to break down ambiguous problems into clear workstreams, plans, and deliverables BS/MS in engineering or related field; PMP (or equivalent) helpful. Benefits We're an employee‑owned innovation partner with a growing US team in Raleigh, NC, part of the Research Triangle. We bring ideas to life-from insight to engineering to pilot manufacture—across consumer and healthcare.