Hobson Prior are looking for a Medical Device Development Project Leader to join a world-wide pharmaceutical company based in Switzerland. Our client focuses on providing pioneering medical solutions to improve the quality of people's lives.
- Thorough project planning.
- Deliver primary packaging and device expertise in a broader cross-functional drug product development team.
- Guide Risk management activities.
- Planning and monitoring of design verification activities (in-house).
- Leading and authoring technical documentation.
- Ensuring a high-quality Design History file.
- Transfer of Design History File to production.
- Bachelor’s or master’s degree in Packaging Science/Engineering or Mechanical Engineering or University
- Level Engineering education.
- A relevant degree in engineering and at least 7 years’ experience in leading device development technical teams in a similar area.
- Understanding of medical device regulations (FDA 21CFR 820, FDA 21CFR Part 4, EU Medical Device Directive, EU Medical Device Regulation)
- Development and writing of technical documentation of drug/device combination products and medical devices, including Design Control process and other applicable regulatory, QA and GMP aspects.
- Test and verification, incl. development of methods and equipment.
- Understanding of Human Factors Engineering, risk management and clinical studies processes and requirements.
- Fluency in English language is required.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.