Engineering - Human Factors Engineer in York

Job Title: Engineering – Human Factors Engineer

Location: Cambridge, UK

Duration: 12 Months

Work Type: Onsite

Overview:

TekWissen is a global workforce management provider throughout the UK, Europe and many other countries in the world. The below client is an American multinational pharmaceutical and biotechnology corporation.

Job Description:

Core role requirements:

• To work with the client\’s 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 provide device usability input/support to device design inputs and human factors study feedback and/or recommended mitigation actions into the DCoE design group and external device design authorities
• To manage and document use-related risk related to assigned projects
• To provide input and support for generation and change control of all the client\’s device Instructions for Use (IFU) documentation
• To assist in the generation of human factors regulatory documentation associated with the Client\’s devices
• To provide guidance to the client personnel on all human factors engineering matters
• 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 and combination product technical language
• Capability to adhere to strict deadlines and prioritise work load under pressure
• Ability to work on own and use initiative where required, or as part of a team

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

Desirable but not essential skills /experience:

• Advanced qualification in Human Factors/Usability or associated faculty
• Appreciation for pharmaceutical/medical device regulatory requirements
• Background in a medical field

TekWissen® Group is an equal opportunity employer supporting workforce diversity.