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Medical Device Technical Expert
Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. We are currently looking for a Medical Device Technical Expert for a 12 month contract to be based in Basel, Switzerland.
Thorough project planning and execution including
- 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 not yet in development
- Providing primary packaging and device expertise in a broader cross-functional drug product development team
- Supporting and coordinating the manufacturing of clinical material and the production scale up, as well as supporting cross functional project teams in the development, review and submission of regulatory dossiers
- Managing and monitoring Human Factors Engineering activities and 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 to be transferred to production
- Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;
- Bachelor’s or Master degree in Packaging Science/Engineering or Mechanical Engineering or University level Engineering education with 7 years’ experience in leading device development technical teams in a similar area
- Fluency in English language incl. technical writing. Proficiency in German/French advantageous
- Good understanding of pharmaceutical development in with complex project / program management and external supplier management and experience in mechanical engineering including product design, testing and verification, and development of methods and equipment
- Understanding of medical device regulations as well as development and writing of technical documentation of drug/device combination products and medical devices
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