Human Factors Technical Specialist

Job Reference: WM - 2148

Location: Cambridge

Salary: £65,000 - £80,000

Job Type: Permanent

Job Description

Human Factors Technical Specialist

Responsibilities:

  • Technical leadership of 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
  • Subject matter expert with the knowledge and expertise to educate and advise colleagues about user-facing features, user profiles and the usability engineering process applied to medical devices
  • Lead on post-market surveillance activities that require usability input, including postproduction risk management reviews
  • Ownership of usability related aspects of the change control process to ensure appropriate usability evaluation as necessary
  • Provide technical leadership and help drive long term strategy within the Human Factors environment
  • Build strong collaborative relationships with all relevant cross-functional partners within the organisation
  • Leadership of programmes of work including technical aspects of regulatory submissions
  • Support the planning, moderating and reporting of formative and summative usability studies as required

About You:

  • Relevant experience in the medical device industry
  • A good degree in a relevant discipline
  • 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
  • Experience of leading human factors activities for successful approvals of regulatory submissions
  • Experience of working closely with design teams

Experience of using strategic thinking in previous roles such as:

  • In depth analysis
  • Creative thinking
  • Goal setting
  • Action planning

It would also be helpful if you have:

  • Experience of mentoring team members
  • The ability to build and sustain productive working relationships across teams
  • The ability to effectively manage and prioritise competing needs

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 don’t 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