This is a great opportunity with a major global company developing medical devices. I am looking for a Human Factors Engineer to work on a 12 month contract in Cambridge.
The team are involved with projects across all business units within the company's global network. A core activity within their device development is management and execution of Human Factors Engineering activities for drug delivery projects and compiling of related documentation for product regulatory submissions.
* Work with the 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 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 device usability input/support to device design inputs and HF study feedback and/or recommended mitigation actions into the design group and external device design authorities.
* To provide input into risk management activities related to assigned projects.
* To provide guidance to personnel on all human factors engineering matters.
* Excellent written English skills.
* Strong ability to develop concise prose suitable for worldwide health care regulatory authorities.
* Comfortable working with all levels of the organisation.
* Strong attention to detail.
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
To apply for this role please forward me a copy of your resume and provide a covering email giving me details of your availability and rate expectations.
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