Senior Program Manager - Medical Devices (Consulting)

Cambridge Design Partnership • Raleigh, NC

3d • Hybrid

About The Position

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.

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.

Nice To Haves

• human factors/usability (IEC 62366) a plus
• PMP (or equivalent) helpful

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior