Medical Device R&D Design 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

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.