Beschreibung
Medical Device Technical Expert - Switzerland - 6 month contractOur client, one of the leading companies within the Life Sciences worldwide is currently seeking a Medical Device Technical Expert-Design History File Expert.
As a medical device technical expert, you will be supporting the technical development of parenteral delivery systems, e.g. drug/device combination products and medical devices.
Major tasks and requirements
- Leading (Authoring/editing documentation and driving to completion) high quality Design History File and successful transfer to production)
- Technical activities including design verification
- Cross functional activities, e.g. review and submission of regulatory dossiers
- Understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive)
- 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
- Understanding of Risk management and Human Factors Engineering
- Test and verification activities, incl. development of methods and equipment
- Bachelor's or Master degree in Science/Engineering or Mechanical Engineering or University level Engineering education.
- 5 years' experience in medical device development
- Fluency in English language is required. Excellent writing skills are required (technical writer)
- Relevant working/residency permit or Swiss/EU-Citizenship required
I am a specialized recruiter, currently taking care of various projects within the Life Science area in Switzerland. If this role is of interest to you or to someone from your network, please send your CV in Word including your hourly rate expectation for immediate consideration.
You can reach me on or at (a.xenitidis'at'realstaffing.com)
Keywords: medical device technical expert, medical devices, design history files, DHF, Human Factors, EU Medical Device Directive, FDA 21CFR 820, English