Day to day tasks would typically span:
* Requirements analysis for medical devices and drug/device combination products
* Leading Risk management activities
* Planning and management of new and ongoing projects, support and challenge technical development as well as test and verification work
* Collaboration with internal and external development partners and stakeholders
* Provide device and primary packaging expertise in a broader cross-functional drug product development team
* Evaluating and challenging technical solutions
* Leading documentation work and the development of a high quality Design History file for later Regulatory Submission; Interfacing with and working across Design Control processes, Regulatory, Quality Assurance and GMP.
* Supporting and coordinating the manufacturing of clinical material and the production scale up.
* Supervision of cross functional teams, mentoring and Personnel management
As such, an ideal candidate would be degree qualified in Mechanical engineering with a minimum of 5 years experience working in Design / Development of Medical Devices in this or similar sectors, and with at least a general understanding of pharmaceutical development. Solid project management skills with a technical background are crucial. Desirable backgrounds would include experience / exposure to Injection molding of plastic components, Product design/Design for manufacture, primary packaging of syringes and cartridges, Equipment building/qualification, Validation of products, equipment and software.
German and English preferred.
This is an exciting new position for someone with leadership aspirations or currently working in a similar role, who is quality oriented, self-motivated, enthusiastic, and with excellent interpersonal skills.
For more information on this vacancy, or any other medical device opportunities, please contact the Senior Consultant Andrew Boroky on 0044 (0) 207 940 2116, or email him at email@example.com