Description
We are looking for a
Medical Device Technical Expert (m/f)
Reference: -en
Start: asap
Duration: 6 MM
Place: in Basel
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Support the technical development of respiratory delivery systems, from early phase activities up to commercialization and production scale up
- Authoring/edit documents regarding the high quality Design History File, drive it to completion and successfully it transfer into production
- Design verification
- Risk management
- Human-factors Engineering
- Definition of product requirements, e.g. drug/device combination products and medical devices
- Cross functional activities, e.g. review and submission of regulatory dossiers
- Collaboration with development partners and stakeholders
- Development and writing of technical documentation for drug/device combination products and medical devices, including Design Control process and applicable regulatory, QA- and GMP-aspects
Your qualifications
- Bachelor's or Master degree in Science/Engineering or Mechanical Engineering or University level Engineering education
- Profound experience in medical device development
- Fluency in English is required as well as excellent writing skills (technical writer)
- Understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive)
- Good understanding of risk management and human-factors engineering
- Good knowledge regarding test and verification activities, incl. development of methods and equipment
Skills:
- R&D scientist
Keywords: Scientist R&D