Medical Device Technical Expert (m/f)

Basel  ‐ Onsite
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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
Start date
ASAP
Duration
6 MM
From
Hays AG
Published at
27.10.2015
Contact person:
Kerstin Werner
Project ID:
1008802
Contract type
Freelance
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