Medical Device: Technical Writer for Design History Files

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. Project planning experience in medical devices: nice to have.

Tasks and responsibilities would typically include (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

Project Planning

Requirements
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).

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