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- Tasks: Lead usability engineering for innovative medical devices, ensuring safety and effectiveness.
- Company: Join a pioneering medical device company in Oxfordshire with a focus on hybrid working.
- Benefits: Enjoy hybrid work options and the chance to impact life-changing technologies.
- Why this job: Shape the future of medical tech while collaborating with diverse teams in a dynamic environment.
- Qualifications: Degree in Human Factors Engineering or related field; experience in medical device usability required.
- Other info: Opportunity to travel and collaborate globally, contributing to innovation and user-driven insights.
The predicted salary is between 48000 - 72000 £ per year.
Halian is proud to partner with a pioneering medical device company based in Oxfordshire offering hybrid working, looking for a Principal Usability Engineerto take ownership of usability engineering across the full product development lifecycle, ensuring innovative implantable and surgical systems are safe, effective, and intuitive for clinical use. This is a high-impact role where youll champion user-centered design and play a key part in shaping the future of advanced medical technologies. Youll work cross-functionally to embed human factors thinking into every stage of development, ensuring compliance with global standards and regulatory frameworks including ISO 62366, FDA, EU MDR, and UK regulations. Your Responsibilities Define and lead the human factors strategy. Plan and execute formative and summative usability studies, including cadaver labs and clinical simulations. Translate user needs into design inputs and risk management documentation. Develop usability engineering files and documentation for global regulatory submissions. Collaborate with design, clinical, engineering, regulatory, and quality teams to integrate usability throughout development. Own use-related risk analysis and ensure alignment with broader risk management processes. Manage external partners conducting usability research, ensuring high-quality outputs. Build deep product knowledge to support usability evaluations and continuous system testing. Maintain traceability across user needs, usability risks, design controls, and verification evidence. Present usability findings to internal and external stakeholders and represent human factors in audits and design reviews. Contribute to innovation and IP development through user-driven insights. Stay current with industry trends, best practices, and evolving regulatory expectations. Travel as needed to support studies and collaborate with global teams. Your Profile Essential: Degree (Bachelors or Masters) in Human Factors Engineering, Ergonomics, Biomedical Engineering, or related field. Extensive experience in human factors engineering within the medical device sector. Proven track record working with surgical or implantable devices and conducting cadaver lab studies. Strong understanding of FDA, EU, and UK usability regulations and ISO 62366. Experience producing usability documentation for regulatory submissions. Comfortable working in multidisciplinary environments with clinical involvement. Desirable: Experience with neuromodulation or urology-related devices. Familiarity with software UI/UX development and system-level evaluation. Knowledge of international regulatory bodies and clinical trial interfaces. Certification in human factors or usability engineering. This position offers the chance to make a real impact in the medical device industry, working on life-changing technologies in a dynamic, collaborative environment. If youre a strategic thinker with a passion for usability and innovation, please apply TPBN1_UKTJ
Principal Usability Engineer employer: Halian Technology Limited
Contact Detail:
Halian Technology Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Usability Engineer
✨Tip Number 1
Network with professionals in the medical device industry, especially those who specialise in usability engineering. Attend relevant conferences or webinars to meet potential colleagues and learn about the latest trends and challenges in the field.
✨Tip Number 2
Familiarise yourself with the specific regulations mentioned in the job description, such as ISO 62366 and FDA guidelines. Being able to discuss these frameworks confidently during interviews will demonstrate your expertise and commitment to compliance.
✨Tip Number 3
Prepare to showcase your experience with usability studies, particularly cadaver labs and clinical simulations. Think of specific examples where you successfully led these studies and how they contributed to product development.
✨Tip Number 4
Stay updated on the latest innovations in human factors engineering and usability within the medical device sector. Being knowledgeable about current trends will help you engage in meaningful discussions during interviews and show your passion for the field.
We think you need these skills to ace Principal Usability Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in human factors engineering, especially within the medical device sector. Emphasise any work you've done with surgical or implantable devices and your familiarity with relevant regulations like ISO 62366.
Craft a Compelling Cover Letter: In your cover letter, express your passion for usability and innovation. Discuss how your background aligns with the responsibilities of the Principal Usability Engineer role and mention specific projects where you have successfully implemented user-centered design.
Showcase Relevant Experience: When detailing your experience, focus on your track record with usability studies, particularly formative and summative studies. Include examples of how you've collaborated with cross-functional teams to integrate usability into product development.
Highlight Regulatory Knowledge: Since compliance with global standards is crucial for this role, make sure to highlight your understanding of FDA, EU, and UK usability regulations. Mention any experience you have producing usability documentation for regulatory submissions.
How to prepare for a job interview at Halian Technology Limited
✨Showcase Your Expertise in Human Factors Engineering
Be prepared to discuss your extensive experience in human factors engineering, particularly within the medical device sector. Highlight specific projects where you successfully implemented user-centred design principles and how they contributed to product safety and effectiveness.
✨Demonstrate Knowledge of Regulatory Standards
Familiarise yourself with key regulations such as ISO 62366, FDA, and EU MDR. During the interview, be ready to explain how you have ensured compliance in past roles and how you would approach regulatory submissions for usability documentation.
✨Prepare for Cross-Functional Collaboration Questions
Since this role involves working with various teams, think of examples that showcase your ability to collaborate effectively. Discuss how you’ve integrated usability into product development processes and how you’ve communicated findings to stakeholders.
✨Highlight Your Innovative Thinking
This position values innovation, so come prepared with ideas on how to enhance usability in medical devices. Share insights from your previous work that led to innovative solutions or improvements, and express your enthusiasm for contributing to future advancements.
