Medical Device Design Engineer – R&D

About the role

We design and build medical devices used in clinical settings. As a Medical Device Design Engineer (R&D) you will own the engineering work from concept through design transfer and commercial launch, working hands‑on in the bench, machine shop, and verification testing while interacting directly with surgeons and clinicians.

Key responsibilities

• Own design and development of new devices and design changes, from user needs through design validation.
• Develop and maintain design control deliverables: user needs, design inputs/outputs, design reviews, traceability matrices, and Design History File documentation.
• Perform risk management per ISO 14971, including hazard analysis, dFMEA and pFMEA, and carry risk controls through verification.
• Write and execute verification and validation protocols, run testing, analyse data and produce regulatory reports.
• Design components and assemblies in SolidWorks, Creo or NX, applying GD&T, tolerance stack‑ups and change‑controlled drawing packages.
• Build prototypes, fixtures and conduct bench testing, iterating quickly on concepts.
• Select materials and processes with biocompatibility, sterilisation and packaging in mind, coordinating ISO 10993 testing when required.
• Partner with contract manufacturers on design for manufacturability, first‑article inspection, process validation and design transfer.
• Support regulatory submissions (510(k), De Novo, PMA, EU MDR) by providing engineering evidence.
• Investigate field complaints, conduct root‑cause analysis and drive design‑related CAPA.
• Represent design engineering during FDA, Notified Body and ISO 13485 audits.

Required profile

• Experience developing medical devices within a regulated design‑control environment.
• Ability to work cross‑functionally with Quality, Regulatory and Manufacturing teams.
• Hands‑on approach with strong problem‑solving skills.

Required skills

• SolidWorks, Creo or NX CAD tools.
• Geometric Dimensioning & Tolerancing (GD&T) and tolerance analysis.
• ISO 14971 risk management, dFMEA and pFMEA.
• ISO 10993 biocompatibility testing coordination.
• Design History File documentation and design control deliverables.
• Regulatory submission knowledge (510(k), De Novo, PMA, EU MDR).
• Familiarity with ISO 13485 and FDA audit processes.