Beschreibung
Exciting Opportunity for an Industrial Manufacturing Engineer for a Medical Device company located in Switzerland - BaselDevelopment Engineer - Sustaining Engineering (MDR)
Overall responsibilities:
Is responsible for the design and development role for the independently update of the technical documentation of existing electromechanical medical devices according to MDR
Responsibilities:
- Update of technical documentation (e.g. Product Risk Management, Design Requirements, Design Outputs) according to MDR regulations and internal processes
- Performs the required activities (e.g. create rationales, decision finding protocols) and generates the appropriate PD documents to ensure compliance with national and international regulations related to medical devices (MDR, US FDA, Japanese PAL, ISO 13485)
- Works 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
Profile:
- Business fluent in German and English
- 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
- MS Office (Work, Excel) knowledge is required.
- Creative/problem-solving skills & Analytical skills
- Willingness to accept responsibility
- Team player
- Reporting - Reports directly to the sustaining engineering lead
Michael Bailey International is acting as an Employment Business in relation to this vacancy.