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Senior Program Manager - Medical Devices (Consulting)

Cambridge Design Partnership · Raleigh, Estados Unidos Da América · Hybrid

  • Escritório em Raleigh
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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.