Design Quality Engineer

Ref 2582313 \| Date: 1 Oct 2026


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.