Medical Device Technical Expert

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, eg drug/device combination products and medical devices
- Cross functional activities, eg 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.