Design Quality Engineer

Bien-Air Surgery; Biel; Sur place; CHF 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Supportive work environment

Innovative fast-growing SME

Role with impact on performance

Ongoing professional development

Résumé du poste

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.

Responsabilités

• 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).

Connaissances

DMR/DHF knowledge

ISO 13485

EU MDR 2017/745

MS Office

PLM system

French (fluent)

English (B2+)

Attention to detail

Team collaboration

Formation

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

Outils

PLM system

Description du poste

Bien-Air Surgery is a growing international company which develops, manufactures and markets high-tech instruments for microsurgery. We have held an enviable position in the international market for many years thanks to our emphasis on invention and innovation, and the high quality of our products and services.

To support our growth, we are looking to add to our team at our site in Bienne a Design Quality Engineer

In this role, you will play a key part in a fast-moving team and participate in the development of our Medical Devices. You will work closely with different departments to ensure the design quality of the final product.

Your Responsibilities:

• Lead and support New Product Development (NPD) and Design Changes by ensuring compliance of activities and documentation to internal QMS requirements as well as to external regulations and standards (FDA, ISO).
• Support Verification & Validation activities to ensure compliance with applicable Design Control requirements.
• Generate and maintain Risk Management File during NPD and Design Changes using principles from ISO 14971.
• Ensure quality assurance according to principles of Design Changes of medical devices during all stages of product development.
• Update existing product documentation in compliance with requirements of MDR.
• Create, review or approve DMR and DHF documentation released during NPD and Design Changes.
• Contribute to generate and maintain User Information Material.
• Contribute to continuous improvement of internal procedures related to NPD, Design Change and Risk Management.
• Become key contributor to product reprocessing methodology and testing (cleaning and sterilization).

Your Profile:

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

What We Also Offer :

• A supportive and collaborative work environment within a family-oriented company structure.
• The opportunity to join an innovative and fast-growing industrial SME.
• A role with real impact on the company’s performance and results.
• Opportunities for continuous learning and ongoing professional development.