Medical Device: Technical Writer for Design History Files

Description

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, 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

• 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