Beschreibung
Within the Design and Development team, we are looking for a Development Engineer who will be updating technical documentation of existing electromechanical medical devices according to MDR
Responsibilities:
Update of technical documentation (eg Product Risk Management, Design Requirements, Design Outputs) according to MDR regulations and internal processes
Performs the required activities (eg 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 Requirements:
BSc or MSc in mechanical, mechatronics, electrical or design quality engineering
At least 3 years of experience in the design and development of medical devices
Business fluent in German and English
MS Office (Work, Excel) knowledge is required.
Creative/problem-solving skills
Analytical skills
Willingness to accept responsibility
Team player
Please send your CVs Kontakt: Luchele Mendes.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.