User-Centred Design/Human Factors Engineer

A contract Human Factors Engineer role exists within device development for the management and execution of Human Factors Engineering activities for drug delivery system projects and compiling of related documentation for product regulatory submissions. The requirement is for a full time, office-based Human Factors Engineer and the role is based in Cambridge UK.

Job Role:

• To work with drug product teams, external design companies and human factors vendors in developing and ensuring timely execution of human factors engineering deliverables including project managing the supply, assembly and testing of materials for use in HF studies
• To assist in the generation of human factors regulatory documentation associated with company devices
• To provide support for the assessment and management of suppliers for human factors, and compliance issues related to the use of devices in the hands of users
• To provide input and support for generation and change control of all device Instructions for Use (IFU) documentation
• To provide input into risk management activities related to assigned projects
• To provide guidance to company personnel on all human factors engineering matters

Education, Skills and Experience:

• Experience with Human Factors Engineering, ideally for combination products with devices
• Excellent project/time management skills
• Excellent IT skills essential - PC literate (rather than Macintosh) with good experience with typical Microsoft Office applications including MS PowerPoint
• Minimum 3 years relevant experience
• Advanced qualification in Human Factors/Usability or associated faculty desired
• Appreciation for pharmaceutical/medical device regulatory requirements desired
• Background in a medical field desired
• Excellent written English skills
• Strong ability to develop concise prose suitable for worldwide healthcare regulatory authorities
• Comfortable working with all levels of the organisation
• Strong attention to detail General requirements
• Ability to work with multiple projects
• Ability to understand medical device technical language

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Weronika Ficek on +44 203 0789 550 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.