Development Engineer

Medexec; Zürich; On-site; CHF 110,000 - 150,000; Full time

Job summary

Medexec is seeking a Development Engineer to own the design and technical documentation of innovative medical devices within the R&D organization. You will translate user needs into clear product requirements and ensure design decisions are structured, traceable and compliant.

Your background in biochemistry, chemistry or materials science will support formulation, compatibility and stability work, and your packaging expertise will drive packaging design and validation.

Qualifications

• Experience drafting design control documentation (DHF, DMR, DDP, URS).
• Knowledge of ISO 13485, ISO 14971, EU MDR and FDA 21 CFR 820.

Responsibilities

• Own design and technical documentation for medical devices within R&D.
• Translate user needs into product requirements and guide technical team.
• Lead packaging development: materials, compatibility, sealing, shelf-life studies.
• Manage risk management in line with ISO 14971 and link design to clinical performance.
• Prepare URS, Design & Development Plans, Device Descriptions and reports.
• Collaborate with R&D, Quality, Regulatory, Clinical and Operations.

Skills

Design controls

Documentation

Regulatory awareness

Education

BSc/MSc in Biochemistry or related

Job description

The Opportunity

As Development Engineer, you'll own the design and technical documentation of innovative medical devices within the R&D organisation. You'll translate user needs into clear product requirements and make sure every design decision is structured, traceable and compliant. Your background in biochemistry, chemistry or materials science will support formulation, compatibility and stability work, and your packaging expertise will drive packaging design and validation.

• 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, then guide the technical team towards the right specifications
• Lead packaging development activities: 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

Experience Required

• 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)
• Working knowledge of ISO 13485, ISO 14971, EU MDR and FDA 21 CFR 820
• Exposure to biomaterials, polymers or peptide-based systems
• Strong attention to detail and the ability to bring structure to complex information

Cultural Alignment

You get real satisfaction from doing things properly.

You like bringing order to innovation, making sure what gets built is well defined, compliant and provably meets its users' needs.

You learn fast, take ownership and seek growth

This is a proprietary, science-backed technology with genuine patient impact

A growing, ambitious company 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