Description
Medical Device Development Project Leader - NOVJP (m/f)
Reference: -en
Start: asap
Duration: 6 MM++
Main tasks:
- Thorough project planning
- Leading the definition of product requirements for packaging, medical devices, delivery systems, e.g. drug/device combination products in which the device is generally already registered but sometimes to be developed
- Leading the collaboration with external development partners
- Provide primary packaging and device expertise in a broader cross-functional drug product development team
- Leading 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
Main qualifications
- Bachelor or Master degree in Packaging Science/Engineering or Mechanical Engineering or University level Engineering education
- In-depth experience in leading device development technical teams in a similar area
- Fluency in English (oral and written), proficiency in German/French advantageous
- Good understanding of pharmaceutical development in general and experience in project / program management of complex projects
- 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
- General understanding of Human Factors Engineering, risk management and clinical studies processes and requirements
Main advantages:
- A very renowned company
- Interesting tasks in a multinational environment
- A city with a high quality of life that perfectly embraces both modern and traditional values
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Svenja Weiß
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