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Senior Human Factors Consultant - Permanent - Bristol - UK

Design
Ref: 435 Date Posted: Tuesday 27 Apr 2021
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The Role

Do you have a strong track record for championing Human Factors Engineering (HFE) in the field of medical devices and combination products? Are you passionate about ensuring HFE is not perceived as a checkbox activity but maximising the return on investment that can be achieved?

If so, then this role could be for you. Our client is an ISO 13485 certified Human Factors and Usability Consultancy, providing expertise to global medical device and pharmaceutical clients.

We’re looking for an ambitious, bright and enthusiastic Human Factors Consultant to join our clients globally recognised team.

Responsibilities include:

  • Responsible for the management, planning and delivery of high quality human factors engineering projects to our clients
  • Conducting formative and validation HFE studies
  • Conducting Use Related Risk Analysis to support identification of risks
  • Mentoring and supporting other members of the team
  • Presenting to, and liaising with clients on a regular basis

Job Requirements:

  • Master degree in Human Factors Engineering or higher
  • A minimum of 5 years relevant experience in Human Factors role within a medical device or pharmaceutical product development environment, or consultancy
  • Demonstrable robust understanding and application of HFE key industry standards (e.g. FDA Guidance, IEC 62366-1, ISO 14971:2019, EU-MDR)
  • Demonstrable knowledge of integrating HFE within the design development process
  • Demonstrable knowledge and experience of HFE study design including protocol writing & US IRB submission processes
  • Demonstrable knowledge of medical device QMS and Design Control Practices (e.g. ISO 13485, FDA QSR)
  • Excellent technical writing and data analysis skills
  • Experience of project management

Essential Commercial Skills

  • Commitment to quality and excellent attention to detail
  • Excellent time management & project management skills
  • Commercial awareness and knowledge of consultancy environment
  • Confident in ability to liaise with colleagues, Clients, suppliers at technical and non-technical levels
  • Excellent communication skills

Personal Skills

  • A genuine passion for applying HFE to improve the design of medial devices and combination products
  • Self-sufficient and willing to take responsibility for own tasks and for completion of work to time and standard
  • Demonstrable integrity and honesty
  • Respectful of others’ opinions and perspectives
  • Collaborative and willing to work as part of a team

Details include:

  • Full time position (37.5hrs) based in Bristol City Centre, with opportunities for flexible working
  • 25 days holiday a year + 8 bank holidays
  • Group Company Pension Scheme
  • Private Healthcare scheme
  • Dedicated employee training budgets

 

Specialists in consultancy


At Medical Engineers we have a range of technical consulting jobs in the medical engineering industry throughout the UK. Requiring a broad range of technical and management skills and most importantly the ability to communicate effectively. Consultancy roles require candidates with unique abilities. Roles vary in length of contract depending on clients’ requirements.

Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

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