Location : Oxfordshire Department : R&D / Engineering Job Type: Full time Contract Type :Permanent Do you have proven experience in human factors engineering for medical devices? Do you have experience producing usability documentation for global regs submissions? If so, we want to hear from you! Amber Therapeutics are looking for a Senior or Principal Usability Engineer to join our dynamic team. This is a full-time hybrid role based at our new custom-built facility in Harwell, Oxfordshire. Amber is a pioneering neuromodulation company dedicated to transforming the lives of patients through advanced medical technology. We specialize in the development of cutting-edge active implantable medical devices. The Role An exciting opportunity to lead and deliver usability engineering and human factors activities across the product development lifecycle for Amber’s neuromodulation systems. You will lead usability test strategies to bring innovative products to market and champion the user through design and development. This role ensures all systems are safe, effective, and intuitive for use, complying with international standards (e.g., ISO 62366) and regulatory requirements (FDA, EU MDR, UK regulations). You will be instrumental in shaping and embedding human factors thinking into the design of implantable and surgical technologies. Key Responsibilities: Lead Amber’s human factors engineering strategy in line with ISO 62366, FDA, UK & EU requirements. Plan and execute usability studies (formative & summative), including cadaver labs and clinical simulations. Translate user needs into design and risk management inputs throughout development. Produce high-quality usability documentation for global regulatory submissions. Work across design, clinical, engineering, regulatory & quality teams to embed usability throughout product development. Provide expert input into risk management, system architecture, and clinical interface design. Ownership of use-related risk analysis, ensuring integration with wider risk management files. Oversee subcontractors conducting usability research, ensuring outputs align with programme requirements. Build strong knowledge of Amber’s neuromodulation systems to support effective usability evaluation. Actively participate in continuous system integration testing to identify usability challenges, design improvements, or opportunities to enhance user experience. Create and maintain usability engineering files including use error analyses and human factor validation protocols. Ensure traceability across user needs, usability risks, design controls, and verification evidence. Present usability findings and recommendations to internal and external stakeholders. Represent human factors in audits and design reviews and approve usability deliverables. Contribute to IP development through user-centred innovation. Keep up to date with trends and best practices in usability, medical devices & regulatory expectations. Travel as required to support studies, user research and collaborate with global stakeholders. Skills & Experience Essential: Bachelor’s or master’s degree in Human Factors Engineering, Ergonomics, Biomedical Engineering, or a related field. Significant experience in human factors engineering for medical devices. Proven track record with surgical or implantable devices and cadaver lab studies. Strong working knowledge of FDA, EU, and UK usability regulations and ISO 62366. Experience producing usability documentation for global regulatory submissions. Background in multidisciplinary development environments with clinical involvement. Desirable: Experience with neuromodulation systems or urology-related devices. Knowledge of software UI/UX development and system-level evaluation. Familiarity with international regulatory bodies and clinical trial interface. Certification in human factors or usability engineering. This position is ideal for an experienced human factors engineer looking for an exciting opportunity to make a meaningful impact in the medical device industry. You will have a strong customer-focused mindset with a deep empathy for user needs. Your strong technical expertise and problem-solving skills will enable you to excel in working on multi-disciplinary projects. This role requires excellent written and verbal communication skills to convey technical information with clarity and precision. You should have the ability to thrive in a fast-paced, collaborative environment, balancing independent contributions with teamwork to deliver innovative solutions in a dynamic, cross-disciplinary setting. About Us Amber Therapeutics is developing a closed-loop neuromodulation therapy able to treat mixed urinary incontinence for the first time and transform the clinical outcome of a very large untreated patient population. Amber’s fully implantable PicostimTM System targets the pudendal nerve with a device that can both stimulate and sense physiological responses. Please refer to our website for further information. What We Offer This is a chance to be part of a ground-breaking team creating life-changing therapies for millions of people globally. You join us at an exciting phase of our development, as we expand the team and accelerate towards our first Pivotal Trial. In addition, we offer a competitive salary commensurate with experience, private healthcare, income protection, life assurance, company pension scheme and 27 days holiday (plus bank holidays). Amber Therapeutics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We look forward to hearing from you. REF-223309