Usability Group Lead

Brief Role Description: We are supporting our client who are a successful manufacturer of Safety Critical Components, in their search for a Usability Group Lead to join their expanding team. Responsibilities: Lead the Human Factors efforts to establish, document, implement and maintain a usability engineering process to provide safety for patients and users which satisfies global regulatory bodies Develop and grow the Usability Team Provide leadership and help drive long term strategy within the Human Factors environment Scope and plan usability activities with the Project Management and Design Teams Support the planning, moderating and reporting of formative and summative usability studies Provide information to other teams about user-facing features, user profiles and the usability engineering process applied to medical devices Follow the change control process to ensure appropriate usability evaluation as necessary Build strong collaborative relationships with all relevant cross-functional partners within the organisation Report on progress of group activities to Head of Systems and Reliability About You: Relevant experience in the medical device industry A good degree in a relevant discipline Experience of growing, developing and leading a group Considerable experience applying human factors methodologies Proven practical experience of use-related risk management (UFMEA) in line with ISO14971 Significant understanding of user and user interface requirements Comprehensive knowledge of the FDA guidance, BS EN 62366, BS EN 60601-1-8, EU MDR and HE75 and other applicable guidelines and standards The ability to build and sustain productive working relationships across teams It would also be helpful if you have: Experience of successful approvals for regulatory submissions The ability to effectively manage and prioritise competing needs Experience of using strategic thinking in previous roles such as: - in depth analysis - creative thinking - goal setting - action planning Job Application: If you would like to be considered for this role, please apply to send a copy of your full CV - or call us now. Whilst this position may not be of interest to you or suit your skills and experience, please dont hesitate to get in contact with a member of the team at Willcox Matthews to understand how we can support you. We receive a large number of applications for all of our positions Therefore, if you have not received a response within 10 working days, your application has unfortunately been unsuccessful on this occasion. Candidates must be eligible to work and live in the UK
Cambridgeshire, England, UK
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