Medical Device Technical Expert

Switzerland  ‐ Onsite
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Description

Medical Device Technical Expert



Medical Device Project Support: Design History File Expert



The successful candidate for this position will support the technical development of respiratory delivery systems within the Inhalation Device & Packaging Development Team, from early phase activities up to commercialisation and production scale-up.



In addition to outstanding documentation and inter-personal skills, a strong technical background in medical devices is crucial. 

 

Tasks and responsibilities (listed in order of importance): 



- Leading (Authoring/editing documentation and driving to completion) high quality Design History File and successful transfer to production)



- Technical activities including design verification 

- Risk management activities

- Human Factors Engineering activities



- Supporting (Communication and coordination activities)



- 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



 Requirements:



- Bachelor’s or Master degree in Science/Engineering or Mechanical Engineering or University level

- Engineering education. 

- 5 years’ experience in medical device development. 

- Fluent English language skills are required. Excellent writing skills are required (technical writer). 



Experience desired (listed in order of importance): 



- 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. 
Start date
n.a
From
Quanta Consultancy Services
Published at
20.11.2015
Contact person:
Lee Mitchell
Project ID:
1024056
Contract type
Freelance
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