|Location: Cambridge, Cambridgeshire||Salary: £30000 - £40000 per annum + Excellent Benefits Package|
|Sector: Human Factors||Specialism:|
|Type: Permanent||Contact: Ian Cowx|
Human Factors Engineer
Cambridge - £30k - £40k
Within this organistion people work together to positively impact health for everyone, everywhere. You have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Join a global leader in the biopharmaceutical industry that is continuously seeking the very best talent who are inspired by a purpose to innovate and bring therapies to patients that significantly improve lives.
- To ensure assigned devices, associated labelling and packaging, and training (if applicable) are designed to be safe and effective for use by intended users within intended environments for all chosen markets
* To work with drug product teams, external design companies and human factors vendors in developing and ensuring timely execution of human factors engineering deliverables for assigned devices
* To assist in the generation of design validation and human factors regulatory documentation for assigned devices
* To provide guidance to other personnel on all human factors engineering matters
- Generate and ensure approval of all human factors engineering documentation for assigned devices
* Provide input and support for risk management activities related to assigned devices
* Provide device usability input/support to device design inputs and device design specification
* Manage all human factors (HF) activities associated with HF vendors, including on boarding of HF vendor, generation of study brief, attainment of HF vendor proposals, assignment of HF vendor, providing all relevant materials and documentation, management of HF studies, and generation and approval of associated reports
* Project manage the supply, assembly and testing of materials for use in HF studies and associated documentation
* Report any adverse findings or adverse events witnessed at HF studies and ensure appropriate action
* Ensure timely execution of HF studies for assigned projects
* Provide HF study feedback and/or recommended mitigation actions into the DCoE design group and external device design authorities
* Provide input and support for generation of assigned device Instructions for Use (IFU), device labelling and packaging
* Design and ensure full change control for IFU documentation where applicable for assigned projects
* Support the generation of device regulatory submission data
* Provide input into risk management activities related to assigned projects ensuring risk files are aligned with human factors activity and feedback
- Degree, HND or equivalent in relevant subject.
* Background of working in teams in the development or trouble shooting of equipment, devices or manufacturing processes by means of human factors evaluations and logical problem solving.
* Excellent IT skills PC literate (rather than Macintosh) with good experience with typical Microsoft Office applications including MS PowerPoint
* Thorough theoretical knowledge and understanding of degree subject
* Able to anticipate what information is required by their colleagues and to disseminate it actively and efficiently.
* Enjoys working within multidisciplinary teams in the development of leading edge designs and technologies
* Ability to plan, organise and prioritise own work with minimal supervision.
* Excellent project/time management skills
* Capable consistently of accurate recording of all data in compliance with SOPs.
* Effective team worker.
This advert was posted by Gold Group - one of the UK's leading niche recruitment consultancies. We span a variety of specialist industries and are the recruitment company to help you find your next career opportunity. We pride ourselves on our commitment to candidates and stick to our ethos of finding the right role for the right person. Visit our website or get in touch today to discuss this role, find out what else we've got or just for a chat about the state of your industry. Services advertised by Gold Group are those of an Agency and/or an Employment Business. Please be aware that we receive a high volume of applications for every role advertised and regularly receive applications from candidates who exceed the job credentials. We will only contact you within the next 14 days if you are selected for interview.