Design Quality Engineer

Bien-Air Surgery; Biel; On-site; CHF 90,000 - 130,000; Full time

Benefits offered by this job

Family-oriented culture

Continuous learning opportunities

Job summary

Bien-Air Surgery in Switzerland is seeking a Design Quality Engineer for our Bienne site to support the development of medical devices and ensure design quality. You will collaborate across departments to guarantee compliance with internal QMS and external standards.

You will drive NPD and design changes, support design verification and validation, update MDR-aligned documentation, and contribute to risk management and product information materials.

Qualifications

• Bachelor’s degree in mechanical, micro-mechanical or biomedical engineering.
• 1–3 years’ experience in quality assurance of medical devices (class IIa or above).
• 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.

Responsibilities

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

Skills

QA medical devices

DMR/DHF knowledge

ISO 13485

EU MDR 2017/745

MS Office

PLM

French (fluent)

English (B2)

Organizational skills

Teamwork

Education

Bachelor’s degree in mechanical/biomedical engineering

Tools

PLM system

Job description

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.