Product Development Engineer, German, Contract, Switzerland

For our Medical Devices client in Zuchwil, we are seeking a Product Development Engineer

Start Date: 16th May 2016
End Date: 23rd December 2016 + extensions
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

We understand that you may wish to know more about the responsibilities of the role before submitting an application, please feel free to submit your CV or contact details via this website or email me and I will be happy to answer any questions you may have.

We look forward to hearing from you,

Kind regards,

Neha Sharma

MBA Michael Bailey Associates

Job Code: 110095/110269

Keywords: product development, medical devices, product development engineer, German, EN ISO 14630:2012, EN ISO 14602:2011, Design, Clinical Risk Management, Technical File, Design History File, documentation, maintenance, implants, instruments, Zuchwil

Michael Bailey International is acting as an Employment Business in relation to this vacancy.