Tasks

  • Support technical activities within the development of medical devices/combination products
  • Support Medical Devices Development, from early phase activities up to commercialization and production scale-up
  • Compile technical documentation: Design History File, Design Control process and other applicable regulatory, QA and GMP aspects
  • Understanding of medical devices regulations (FDA, 21CFR 820, EU Medical Device Directive)
  • Product design/ Design for manufacturing
  • Testing and Verification (development of methods and equipment)
  • Understanding of Human Factors Engineering and Risk Management

PROFILE

  • Master degree in Science/Engineering, Mechanical Engineering or equivalent
  • Good Knowledge in primary containers (syringes, cartridges…)
  • Good Knowledge of ISO 13485 and GMP in general
  • General Understanding of Human Factors Engineering and Risk Management
  • English Fluent, German or French is a plus