Development Engineer – Medical Devices

About the role

As a Development Engineer you will play a key role in the design and documentation of innovative medical devices within the R&D organisation. You will develop and maintain the technical documentation required under design control, ensuring compliance with ISO 13485, FDA 21 CFR 820 and EU MDR.

Key responsibilities

• Develop, review and maintain design control documentation: design inputs/outputs, V&V reports, risk management files and DHFs.
• Support device and packaging development: material specifications, design verification testing, shelf‑life and packaging integrity studies.
• Prepare Device Descriptions, Design & Development Plans, URS and technical reports in line with ISO 13485 and FDA QSR.
• Support risk management in line with ISO 14971, linking design, verification and clinical performance.
• Plan testing, evaluate data and interpret results on product and packaging performance.
• Generate and maintain Change Control, CAPA and Design Review documentation.
• Evaluate materials and processes, working with suppliers on formulation and packaging components.
• Improve design control processes and documentation templates.
• Provide technical documentation and justifications for regulatory submissions.
• Collaborate with R&D, Quality, Regulatory, Clinical and Operations teams.

Required profile

• BSc/MSc in Biochemistry, Chemistry, Chemical Engineering, Materials Science, Biomedical or Packaging Engineering.
• 3–5+ years in medical device development and manufacturing, ideally in dental, pharma or life‑sciences (CMO experience a plus).
• Proven authorship of design control documentation and technical writing (DHF, DMR, DDP).
• Working knowledge of ISO 13485, ISO 14971, EU MDR and FDA 21 CFR 820.
• Packaging design and validation experience, including material compatibility, sealing and stability testing.
• Strong understanding of chemical and material properties, ideally with biomaterials, polymers or peptide‑based systems.

Required skills

• Design control documentation (DHF, DMR, DDP).
• Risk management (ISO 14971).
• Regulatory standards: ISO 13485, FDA 21 CFR 820, EU MDR.
• Packaging design and validation.
• Material specification and testing.
• Document control systems (QMS or PLM tools).

What we offer

• Impactful product launches where your work is visible and valued.
• Cutting‑edge R&D facilities and cross‑functional collaboration.
• Real career development as the R&D organisation scales.