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Mechanical Engineer – Programme Manager – Drug Delivery Devices

Newton Colmore Consulting Ltd · Cambridge

Senior 🇬🇧 English
mechanical design EN60601 ISO 13485 design controls for combination products

Job description

About the role

We are seeking a Mechanical Engineer with strong programme‑management experience to lead multiple drug‑delivery device programmes in Cambridge. You will drive the development of next‑generation delivery platforms, mentor junior engineers, and translate complex user, clinical and regulatory requirements into robust mechanical solutions.

Key responsibilities

  • Lead and coordinate several concurrent programmes focused on autoinjectors, inhalers, infusion systems, wearable devices and other combination products.
  • Own core mechanical design activities while also providing technical guidance to junior engineers.
  • Translate user, clinical and regulatory requirements into detailed mechanical designs.
  • Collaborate with internal teams, external partners, clients and suppliers to ensure efficient programme delivery.
  • Manage stakeholder communications, project updates and cross‑functional coordination.
  • Ensure compliance with relevant standards and commercial viability throughout the product lifecycle.

Required profile

  • Mechanical Engineering degree (BEng/MEng); MSc or PhD is a plus.
  • Significant experience in the development of regulated drug‑delivery or electro‑mechanical medical devices.
  • Proven track record of taking medical products from development through market launch.
  • Commercially minded with understanding of regulatory, manufacturing and market considerations.
  • Comfortable working in a highly collaborative, multidisciplinary environment.

Required skills

  • Mechanical design and development of electro‑mechanical medical devices.
  • Knowledge of EN60601 standards.
  • Knowledge of ISO 13485 and design‑control requirements for combination products.

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Published 2 months ago

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Newton Colmore Consulting Ltd

Cambridge