Beschreibung
We are looking for a Senior Design and Development Engineer who will work on MDR documentation projects for our Medical Device client based in the German part of Switzerland.
Responsibilities:
- Independently update the technical documentation of existing electromechanical medical devices according to MDR
- Update of technical documentation (eg Product Risk Management, Design Requirements, Design Outputs) according to MDR regulations and internal processes
- Perform the required activities (eg create rationales, decision finding protocols) and generate the appropriate PD documents to ensure compliance with national and international regulations related to medical devices (MDR, US FDA, Japanese PAL, ISO 13485)
- Work together with regulatory, quality, technical engineering, external suppliers and manufacturing to release the documents
- Knowledge and compliance with laws and policies that apply to the job and ensure a high level of professionalism, ethics and compliance at all time.
Requirements:
- Master/bachelor's degree in mechanical/mechatronics/electrical or design quality engineering
- At least 3 years of experience in the design and development of medical devices
- Experienced with MDR and other Medical Device regulations
- Business fluent in German and English
Kontakt: Luchele Mendes
Michael Bailey International is acting as an Employment Business in relation to this vacancy.