Development Engineer – Medical Devices (Zurich)

About the role

The Development Engineer will own the design and technical documentation of innovative medical devices within the R&D organisation. You will translate user needs into clear product requirements and ensure every design decision is structured, traceable and compliant. The role combines formulation, compatibility, stability work and packaging expertise to bring concepts to market.

Key responsibilities

• Develop and maintain design control documentation (design inputs/outputs, V&V reports, risk management files, DHFs).
• Translate user and customer needs into product requirements and guide the technical team.
• Lead packaging development activities, including material specifications, compatibility, sealing, shelf‑life and stability studies.
• Run risk management in line with ISO 14971, linking design, verification and clinical performance.
• Prepare URS, Design & Development Plans, Device Descriptions and technical reports.
• Manage Change Control, CAPA and Design Review documentation.
• Collaborate with suppliers and CMOs on formulation and packaging components.
• Support regulatory submissions and audits with technical documentation.
• Work closely 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 of experience in medical device development, preferably in dental, pharma or life‑sciences.
• Hands‑on authorship of design control documentation (DHF, DMR, DDP, URS).
• Working knowledge of ISO 13485, ISO 14971, EU MDR and FDA 21 CFR 820.
• Packaging design and validation experience.
• Exposure to biomaterials, polymers or peptide‑based systems.
• Strong attention to detail and ability to structure complex information.

Required skills

• ISO 13485
• ISO 14971
• EU MDR
• FDA 21 CFR 820
• Risk management
• Packaging design
• Stability studies
• Change control
• CAPA