Beschreibung
For our Medical Devices client in Zuchwil, we are seeking a Product Development Engineer
Start Date: 16th May 2016
End Date: 30th September 2016
Location: Zuchwil
Language: English, German is also highly preferred
Your Role:
- Responsible for the maintenance of existing implants and instruments
- Responsible for the maintenance of existing Technical File and Design History File documentation
- Understand and comprehend existing techfile documentation in English
- Write Standard Evaluation EN ISO 14630:2012 and EN ISO 14602:2011
- Write Design and Clinical Risk Management
- Information exchange and collaboration between internal, local, external and foreign partners is essential. Close cooperation with internal departments, domestic and international authorities as well as the conscientious preparation of the required documents ensures compliance with Medical Device Regulations (EU MDD, US FDA, JP PAL)
Your Experience:
- Degree in Engineering (or related practical experience in regulated industry)
- Experience in the maintenance and/or writing of documentation, including: Technical File, Design and Clinical Risk Management documentation
- Team Player, strong initiative and effective communication skills
- Interest in link between medicine & technology
- Fluency in English, German is a plus
- EN ISO 14630:2012 & EN ISO 14602:2011 preferred
Michael Bailey International is acting as an Employment Business in relation to this vacancy.