Description
We are looking for a
Medical Device Technical Expert - DHF Manager (m/f)
Reference: -en
Start: asap
Duration: 8 MM+
Place: in Basel
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Support technical activities within the development of parenteral delivery systems, e.g. drug/device combination products and medical devices
- Support the product design/design for manufacture
- Support test and verification, incl. development of methods and equipment
- Ensure product compliance for the assigned projects
- Compile Design Control documentation and contribute to a high quality Design History file
- Establish/contribute to the documentation strategy
- Support development of Quality Assurance Agreements with third parties
Your qualifications
- Master degree in Science/Engineering or Mechanical Engineering or University level engineering education
- Excellent skills in English
- Experience in pre-filled-syringe device development, from early phase activities up to commercialisation and production scale-up
- Experience in Medical device quality assurance
- Knowledge of DHF compilation, including Design Control process and other applicable regulatory, QA and GMP aspects
- Understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive)
- Good technical knowledge about primary containers, e.g. syringes and cartridges
Skills:
- R&D scientist
Keywords: Scientist R&D