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- Tasks: Lead innovative Human Factors projects for medical devices and ensure regulatory compliance.
- Company: Join Eakin Healthcare, a leader in medical device innovation with a collaborative culture.
- Benefits: Enjoy 25 days holiday, health cash plan, blended working, and more perks.
- Why this job: Make a real impact in healthcare by enhancing user experience in medical devices.
- Qualifications: 4+ years in Human Factors for medical devices and a relevant degree required.
- Other info: Dynamic role with opportunities for growth and collaboration across teams.
The predicted salary is between 36000 - 60000 ÂŁ per year.
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
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
- 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.
- Experience 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
- 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.
- 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. 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.
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Product Management and Research
Industries: Medical Equipment Manufacturing
Human Factors Specialist in Coleraine employer: Eakin Healthcare
Contact Detail:
Eakin Healthcare Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Human Factors Specialist in Coleraine
✨Tip Number 1
Network like a pro! Reach out to current employees at Eakin Healthcare on LinkedIn or through mutual connections. A friendly chat can give you insider info and might just get your foot in the door.
✨Tip Number 2
Prepare for the interview by diving deep into Human Factors principles and recent regulatory changes. Show us you’re not just familiar with the basics but are genuinely passionate about the field and how it impacts medical devices.
✨Tip Number 3
Practice your storytelling skills! Be ready to share specific examples of your past projects and how you’ve influenced product design. We love hearing about real-life experiences that showcase your expertise.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining our team at Eakin Healthcare.
We think you need these skills to ace Human Factors Specialist in Coleraine
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Human Factors Specialist role. Highlight your relevant experience in medical devices and showcase how your skills align with our needs at Eakin Healthcare.
Showcase Your Expertise: Don’t hold back on demonstrating your understanding of Human Factors principles and regulatory frameworks. We want to see how you’ve applied this knowledge in past projects, so be specific!
Be Clear and Concise: When writing your application, keep it straightforward and to the point. Use clear language and avoid jargon where possible. We appreciate a well-structured application that’s easy to read.
Apply Through Our Website: We encourage you to submit your application directly through our website. It’s the best way to ensure it gets into the right hands and helps us get to know you better!
How to prepare for a job interview at Eakin Healthcare
✨Know Your Human Factors Inside Out
Make sure you brush up on your knowledge of Human Factors principles, especially as they relate to medical devices. Be prepared to discuss how you've applied these principles in past projects and how they align with regulatory frameworks like IEC62366 and FDA regulations.
✨Showcase Your Project Management Skills
Since the role involves managing multiple projects, be ready to share specific examples of how you've successfully led Human Factors programmes. Highlight your ability to juggle tasks while ensuring high-quality outcomes and compliance with regulations.
✨Demonstrate Collaboration and Communication
This position requires working closely with various teams. Prepare to discuss how you've effectively collaborated with R&D, Marketing, and QA/RA functions in the past. Share examples of how you’ve raised awareness of Human Factors principles within a team or organisation.
✨Be Ready for Regulatory Discussions
Familiarise yourself with the latest developments in regulatory compliance related to medical devices. Be prepared to discuss how you stay updated on changes and how you can enhance internal understanding of MDR regulations and ISO standards.
