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Human Factors Engineer

Location: Cambridge, Cambridgeshire Salary: Up to £1000000 per annum + Benefits
Sector: Human Factors Specialism:
Type: Permanent Contact: Ian Cowx

Human Factors Engineer
Cambridge, United Kingdom.
£DOE + Benefits.

Job Purpose:

Working as part of the Human Factors Engineering team the principal aim of the role is 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.
Other tasks include assisting in the generation of design validation and Human Factors regulatory documentation, managing all interfaces with Human Factors vendors for assigned devices including project management of material supply to Human Factors study sites, and providing guidance to personnel on all Human Factors engineering matters.

Qualifications & Experience:

  • Degree, HND or equivalent in relevant subject and but ideally possess an advanced qualification in Human Factors / Usability / Industrial Design or associated faculty
  • 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
  • Experience working in medical device design or a similar highly regulated environment
  • 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
  • Good design ability with keen eye for layout and content appropriateness
  • Excellent IT skills PC literate (rather than Macintosh) with good experience with typical Microsoft Office applications including MS PowerPoint.

The Role Summary:

  • The chosen candidate will be based in Cambridge working within the global drug delivery department who engage in projects across all business units and therapy areas within a global network.
  • This position is available for a full time, office-based Human Factors Engineer with experience in usability of medical products.
  • Generate and ensure approval of all Medical Device 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 activities associated with Human Factors vendors, including on boarding of the vendor, generation of study brief, attainment of the vendor proposals, assignment of 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 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
  • Assist with all design validation activities for assigned projects including clinical study support, complaints analysis and justifications for not performing human factors where applicable.
  • 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
  • Assist in the application of HF engineering principles and controls for all device development projects
  • Support and conduct human factors research to augment present and future device projects including in-house laboratory testing and external research with the support of contract staff/vendors
  • Support continuous improvement activities as they relate to design validation/human factors

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. A copy of our privacy policy can be found here: https://www.goldgroup.co.uk/about-us/privacy-policy. Gold Group is an equal opportunity & diversity employer. A copy of our equal opportunity & diversity policy can be found here: https://www.goldgroup.co.uk/about-us/equality-and-diversity-policy

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