Biomedical Engineer - Project Manager

Bien-Air Surgery SA

Bienne
Apply

Bien-Air 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 :

Biomedical Engineer - Project Manager

 

This engineer will play a key role in a fast-moving team and participate in the development of our Medical Devices.

 

Roles and Responsibilities:

  • Coordinate and lead a cross-functional project team during the development of new products in the field of microsurgery across all product development stages
  • Drive the release of project deliverables and feed Technical Files in accordance with established Design Control principles
  • Create or approve DMR and DHF documentation
  • Responsible to generate and maintain Risk Management File using principles of ISO 14971.
  • Support New Product Development (NPD) and Design Change by ensuring compliance of activities and documentation with internal QMS requirements and with external regulations and standards (FDA, ISO)
  • Ensure continuous improvement and maintain up to date our internal procedures related to NPD, Design Change and Risk Management

 

Qualifications & experience required:

  • At least a Bachelor Degree in mechanical, micro-mechanical or biomedical engineering
  • 3-5 years experience in the development of Medical Devices with proven experience in leading development projects
  • Experience in complying with Design Controls and demonstrated knowledge of FDA QSR, ISO 13485 QMS and ISO 14971 Risk Management for Medical Devices
  • Knowledge of IEC 60601 family of standards and IEC 62304 is a plus
  • Fluent in French or German, with good knowledge of English (a minimum of upper Intermediate [B2] to Advanced [C1]). Basic knowledge in French remains mandatory
  • Advanced technical writing skills in English
  • Strong organizational skills and ability to prioritize tasks to meet established schedules
  • Open-minded personality with the ability to quickly integrate in a team

 

 

We are offering successful applicants the opportunity to join an internationally renowned company, with attractive working conditions and benefits, within a high-tech environment.

 

Complete applications should be sent to Write an email

 

Contact

Apply