Medical Device Technical Expert

For our client in Basel we are looking for a Medical Device Technical Expert for a 6 month contract.
Place: Basel
Period: ASAP-30.06.2017
Workload: 100%

Main Tasks:
* Compile Design Control documentation and contributing to a high quality Design History file. Author and Review of design history file relevant documents. Ensure quality and compliance to applicable regulations of the DHF elements of the assigned projects;
* Ensure device design development in compliance of the regulations and at high quality;
* Consult on the development and/or optimization of the manufacturing processes for medical devices and combination products.
Other Tasks:
* Plan and lead technical activities;
* Manage technical development activities in collaboration with internal development partners;
* Lead the collaboration with external development partners;
* Monitor work progress according to plan.
* Lead or contribute in Risk management activities;
* Support in Human Factors Engineering activities;
* Support DRA to prepare Medical Device/Combination Product pre-registration documents and answer health authority questions.

* Review of medical device and/or packaging-related testing documents;
* Generate/Review of Design Control-, Risk Management-Human Factor and qualification documents;
* Propose medical device and/or packaging specifications.

For more information, please contact:
Anna Chmura
(see below)