To strengthen our team in Switzerland we are looking for Medical Device Project Development Manager. As a Medical Device Project Development Manager, you play a key role in the research and the development of new class I II or III medical devices (instruments, apparatus, implants, in vitro reagent).
R&D Engineer - Medical Device
A Medical device engineers, who will design medical equipment for doctor's practices, hospitals and private individuals. These medical devices may be of different kinds: they may be surgical equipment, therapeutic equipment, scanners / MRI, etc.
- Design and develop Medical Devices
- Ensure the documentation (DHF)
- Ensure the development steps from initial design to design transfer (design controls, design verification...)
- Coordination of development between all departments (R&D, QA, RA, Operations...)
- Specify and perform acceptance tests (performance, statistical quality, verification...)
- Ensure compliance with regulatory and regulatory requirements (FDA, CE Marking, ISO 13485)
- Provide Technical Documentation and build up
- MSc in Mechanical, Bioengineering or Embedded Systems Engineering (ETH...) with emphasis on Medical Device Development
- Professional experience in R&D of Medical Devices
- 4/5 years experience in a similar industry (Medical Devices - Technologies / Pharmaceutical)
- Applied knowledge of FDA and International Medical Device Regulations (ISO 13485...)
- Quality Management and Risk Management.
- Enjoy working in a multidisciplinary team
- Strong verbal and writing communication capabilities
- Languages : English fluent, German is a plus
Mr Maxime KAPPS
Recruitment Manager Life Science