Human Factors Specialist

WHY JOIN US?

We’re good at what we do – come and join us and you can benefit from:

• Blended Working
• Bonus
• 25 days holiday plus bank holidays (rising to 28)
• Option to buy holiday days
• Health Cash Plan
• Pension
• Life Assurance
• Enhanced Maternity/Paternity
• Cycle to Work Scheme
• Referral Scheme
• Long Service Awards
• Free Parking

Reporting to the Head of Clinical and Regulatory Affairs, this is an exciting opportunity to play an important role within Eakin Healthcare. Expansion and diversification of our product portfolio necessitates an experienced Human Factors Specialist to support the team in developing innovative medical devices and MDR remediation. Working closely with our Research and Development, and Commercial teams, you will be responsible for managing multiple projects within the Eakin Healthcare portfolio.

Ideally this role will be based at our Coleraine site. However, remote working options with monthly on‑site visits may be considered.

• Develop pragmatic Human Factors strategies for new and ongoing projects that ensure alignment with regulatory compliance.
• Utilise in‑depth understanding of Human Factors principles, user needs and regulatory frameworks to plan and deliver high quality Formative and Summative studies with limited guidance.
• Confidently plan and deliver high quality documentation for a range of Human Factors activities, including and not limited to Expert reviews, Use‑related Risk Analysis, Known Use Issues Reports and Threshold Analysis Reports for medical devices.
• Actively influence new product design by generating and validating user requirements.
• Champion the development of established and new processes to keep internal practices up to date.

• Remain up to date with impending changes and developments regarding regulatory compliance.
• Provide support to enhance internal understanding of MDR regulations, ISO
  13485, ISO
  14971, IEC
  62366 and FDA Human Factors regulations.

• Collaborate with R&D, Marketing and QA/RA functions within the Eakin Healthcare Group and provide Human Factor support as required.
• Raise awareness and understanding of Human Factors principles internally within the company through actively promoting the discipline and being seen as a subject matter expert that others turn to for guidance and expertise.

• To adhere to the company’s Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible
• To be responsible for your own health and safety and that of your colleagues, in accordance with the company’s Health and Safety policy
• To adhere to the company’s Quality policy and Environmental policy
• To undertake other duties as may be reasonably required

• 4+ years of experience in leading full Human Factors programmes in the field of medical devices.
• Expert understanding of Human Factors as a discipline, including documentation, studies, and best practices.
• Experience in championing HF and usability, ensuring it is kept at the core of product development.
• Mentoring colleagues in the application of Human Factors techniques and approaches during product development.
• An understanding of up‑to‑date regulatory frameworks surrounding medical device development, including IEC
  62366 and FDA Human Factors regulations.
• Degree educated in a relevant discipline.
• Experience with Class IIa and Class IIb respiratory medical devices.

• Working with Operations, Regulatory and the R&D team to support Human Factors activities and provide advice and support to peers
• Collaborating with Commercial functions across Eakin Healthcare Group to support gathering of usability data for market launch and on‑going device marketing activities
• Group wide QA/RA functions to provide clinical support for continuous improvement

• End‑users
• Regulatory bodies
• Research agencies

• Ability/willingness to develop within the role
• Ability/willingness to attend training courses in relation to the role and the needs of the department
• Ability/willingness to travel to…