Usability Engineer

• Lead and coordinate human factors/usability engineering activities in collaboration with product development, quality, regulatory, manufacturing, and clinical teams.
• Continuously develop use analysis in partnership with the risk management team.
• Drive product improvement by providing feedback on UX, functionality, and complaints handling, ensuring an outstanding user experience.
• Conduct a range of qualitative and quantitative research techniques.
• Create usability engineering documentation, e.g., Usability Engineering File (UEF), Use Specifications, Task Analysis, Use Error Analysis, uFMEA, etc., as part of a wider medical product development process.
• Conduct formative feasibility studies, design of experiments, and simulations to establish robust specifications.
• Organize and manage Summative Evaluation studies.
• Ensure compliance with all relevant regulatory standards (e.g., MDR, 21CFR 820, ISO 13485) and quality management systems.
• Participate in design reviews, risk management, FMEA sessions, and root cause analyses as needed.
• Stay updated with industry trends, advancements, and regulatory changes and influence the organization on usability-related policies, procedures, and practices.

• Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• Product development, design, or engineering experience, ideally using ISO 13485 and ISO 14971.
• Demonstrated interest, and ideally experience, in medical devices.
• Experience working within a medical device Quality Management System (ISO 13485). Hands-on expertise in human factors/usability engineering (FDA Guidance, IEC 62366-1, and AAMI Human Factors standards).
• Proven track record of creating usability engineering files for medical devices, ideally active implantable devices.
• A proactive, results-driven mindset with a keen eye for quality and innovation.
• Experience in developing and conducting design validation testing for the long-term viability of implantable devices and managing external suppliers and vendors.
• Familiarity with medical device regulations and standards (e.g., MDR, ISO 13485, ISO 14971, ISO 10993, FDA 21 CFR 820), quality management systems (QMS), and document control processes.
• Experience writing and delivering reports and technical summaries for clinical submissions and regulatory agencies.
• Excellent problem-solving skills and attention to detail.
• Effective communication and teamwork abilities.
• Ability to work in a fast-paced startup environment and manage multiple projects simultaneously.
• Fluency in English; additional European languages are a plus.

Join AMT Medical, a dynamic scale-up poised to redefine cardiac care. Positioned at the forefront of innovation, AMT Medical offers a collaborative and flexible work environment where your contributions significantly impact patient outcomes.  Based in Utrecht and Ede, AMT Medical offers a competitive salary and benefits package, along with substantial opportunities for professional growth and leadership development.

How to Apply: 

Interested candidates are invited to send their CV and a cover letter to our recruiter, Ivor Duif, at Unity Partners:

• Email: ivor@unitypartners.nl
• Phone: +31 20 89 38 606. Please reference Job ID: AMT05032025/4 in all communications.