Development Engineer - Regenerative Medicine

About the role

A company at an inflection point, with strong investor backing, an expanding product pipeline and new R&D capability being built across Europe and the US, is looking for a Development Engineer in the Zurich region. You will own the design and technical documentation of innovative medical devices within the R&D organisation, translating user needs into clear product requirements so that every design decision is structured, traceable and compliant.

Key responsibilities

• Develop and maintain design control documentation: design inputs/outputs, V&V reports, risk management files and DHFs
• Translate user and customer needs into product requirements and guide the technical team toward the right specifications
• Lead packaging development: 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
• Work with suppliers and CMOs on formulation and packaging components
• Support regulatory submissions and audits with technical documentation
• Collaborate with R&D, Quality, Regulatory, Clinical and Operations

Required profile

• BSc/MSc in Biochemistry, Chemistry, Chemical Engineering, Materials Science, Biomedical or Packaging Engineering
• 3-5+ years in medical device development, ideally in dental, pharma or life sciences (CMO experience a plus)
• Hands-on authorship of design control documentation (DHF, DMR, DDP, URS)
• Experience with biomaterials, polymers or peptide-based systems

Required skills

• Working knowledge of ISO 13485, ISO 14971, EU MDR and FDA 21 CFR 820
• Packaging design and validation experience
• Strong attention to detail and the ability to bring structure to complex information

What we offer

• Real ownership and visible impact in a growing, ambitious company
• Cutting-edge R&D facilities and cross-functional collaboration
• Real career development as the R&D organisation scales