|Location: Cambridge, Cambridgeshire||Salary: £40000 - £50000 per annum + Benefits|
|Sector: Human Factors||Specialism:|
|Type: Permanent||Contact: Ian Cowx|
Senior Human Factors Engineer.
£40,000 - £50,000 + excellent benefits package.
Medical / Pharmaceutical product design environment.
- 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 the companies 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 manage all interfaces with Human Factors vendors for assigned devices including project management of material supply to study sites
- To provide guidance to 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 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 protocols and 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
- Support internal and external audits of the Departments Quality System 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.