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
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