At Eakin Healthcare, we put patients at the heart of everything we do. We are a family-owned global medical device company with a proud heritage of innovation and care. We deliver innovative solutions across Ostomy, Respiratory, and Surgical therapies, along with our Respond home delivery service. Founded over 50 years ago, we now have a team of over 700 dedicated people across three UK manufacturing sites, 12 international sales and distribution centres and export to over 60 countries. We’ve been recognised as a Great Place to Work® ! And we’re proud to be named among the Best Workplaces in Healthcare and Best Workplaces for Women. At Eakin Healthcare, we’re united by one mission: working together to improve lives - just like we’ve been doing for over five decades. 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 Wellbeing Programme Health Cash Plan Pension Life Assurance Enhanced Maternity/Paternity Cycle to Work Scheme Referral Scheme Long Service Awards Free Parking ABOUT THE ROLE 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. KEY RESPONSIBILITIES Human Factors activities 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. Regulatory compliance and documentation Remain up to date with impending changes and developments regarding regulatory compliance. Provide support to enhance internal understanding of MDR regulations, ISO13485, ISO14971, IEC62366 and FDA Human Factors regulations. Collaboration and Stakeholder Engagement 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. Other 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 WHAT WE’RE LOOKING FOR Essential 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 IEC62366 and FDA Human Factors regulations. Degree educated in a relevant discipline. Desirable CIEHF chartership. E xperience with Class IIa and Class IIb respiratory medical devices. KEY WORKING RELATIONSHIPS Internal 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 External Healthcare professionals End-users Regulatory bodies Research agencies ADDITIONAL INFORMATION 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 other Eakin Group sites as needed COMPETENCIES Customer Focus Building strong customer relationships and delivering customer-centric solutions. Global Perspective Taking a broad view when approaching issues, using a global lens. Optimizes Work Processes Knowing the most effective and efficient processes to get things done, with a focus on continuous improvement. Builds Networks Effectively building formal and informal relationship networks inside and outside the organization. Values Differences Recognising the value that different perspectives and cultures bring to an organisation. Communicates Effectively Developing and delivering multi-mode communications that convey a clear understanding of the unique needs of different audiences. Instills Trust Gaining the confidence and trust of others through honesty, integrity and authenticity. Nimble Learning Actively learning through experimentation when tackling new problems, using both successes and failures as learning fodder. SP