We are looking for a development engineer for the orthopaedic development area to support on going projects.
This is a temporary contract till end of December 2018. Tasks: - be responsible for technical engineering support of different initiatives driven by manufacturing (transfers, harmonization, process changes, etc.). - update registration relevant documentation of the Design History File to meet current standards and requirements (e.g. risk management documents, functional & design requirements, verification &validation activities). - lead optimizations and design changes and ensure proper communication and timing with manufacturing and shared services. - collaborate with the technical engineering office, write test methods and setups, complete testing requirements and write verification & validation reports. 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). Requirements: degree in engineering or related discipline
Knowledge and experience in medical devices product development
Experience in reviewing and writing DHF,
Fluency in English and German is essential
Michael Bailey International is acting as an Employment Business in relation to this vacancy.