Design Quality Engineer - Medical Devices (Impact & Growth)

Bien-Air Surgery; Biel; On-site; CHF 90,000 - 120,000; Full time

Benefits offered by this job

Supportive work environment

Innovative fast-growing SME

Role with impact on performance

Ongoing professional development

Job summary

Bien-Air Surgery is seeking a Design Quality Engineer to join their team in Bienne. You will ensure design quality of medical devices, align with QMS requirements, and collaborate with multiple departments on NPD and design changes.

The role requires ISO 13485 experience, MDR knowledge, and strong organizational skills, with fluency in French and English. A supportive SME environment and opportunities for development are offered.

Qualifications

• Bachelor’s degree in mechanical, micro-mechanical or biomedical engineering.
• 1–3 years’ experience in quality assurance of medical devices, ideally class IIa or above.
• Demonstrated knowledge of DMR and DHF structure and contents.
• Experience with ISO 13485 QMS and Risk Management for Medical Devices.
• Experience with EU MDR 2017/745.
• Computer skills: MS Office suite, and PLM system.
• Fluent in French, with good knowledge of English (B2 or higher).
• Strong organizational and follow-up skills, attention to detail.
• Open-minded personality with the ability to quickly integrate a team.

Responsibilities

• Lead and support NPD and Design Changes by ensuring compliance with QMS and external regulations.
• Support Verification & Validation to ensure Design Control compliance.
• Generate and maintain Risk Management File during NPD and Design Changes per ISO 14971.
• Ensure quality assurance during all stages of product development.
• Update product documentation in line with MDR requirements.
• Create, review or approve DMR and DHF documents released during NPD and Design Changes.
• Contribute to User Information Material and continuous improvement of procedures.
• Contribute to product reprocessing methodology and testing (cleaning/sterilization).

Skills

DMR/DHF knowledge

ISO 13485

EU MDR 2017/745

MS Office

PLM system

French (fluent)

English (B2+)

Attention to detail

Team collaboration

Education

Bachelor’s degree in mechanical, micro-mechanical or biomedical engineering

Tools

PLM system

Job description

Bien-Air Surgery is seeking a Design Quality Engineer to join their team in Bienne. You will ensure design quality of medical devices, align with QMS requirements, and collaborate with multiple departments on NPD and design changes.

The role requires ISO 13485 experience, MDR knowledge, and strong organizational skills, with fluency in French and English. A supportive SME environment and opportunities for development are offered.