Medical Device Development Project Leader - Basel
Jasmin Baumgartner is recruiting for a Medical Device Development Project Leader join a global medical device company at their site based in Basel on a contract basis for 12 months with likelihood of extension.
The main purpose of the role will be to:
- Offer primary packaging and device expertise in a wider cross-functional drug product development team.
- Lead Risk management activities.
- Ensure a high-quality Design History file including the transfer of the Design History file to production.
Further responsibilities will include:
- Leading the definition of product requirements for packaging, medical devices, delivery systems, such as combination products in which the device is generally already registered but every so often needs to be developed.
- Leading the collaboration with external development partners, such as monitoring of work progress according to plan.
- Monitoring, supporting and challenge technical development as well as test and verification work.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Bachelor's or Master degree in Packaging Science/Engineering or Mechanical Engineering or University level Engineering education.
- Understanding of medical device regulations (FDA 21CFR 820, FDA 21CFR Part 4, EU Medical Device Directive, EU Medical Device Regulation).
- Previous experience writing of technical documentation of drug/device combination products and medical devices, including Design Control process and other applicable regulatory, QA and GMP aspects.
Please quote reference 45467 in all correspondence