Usability Engineer

Job

We are actively seeking a Usability Engineer to join AMT Medical's innovative team. AMT aims to transform Coronary Artery Bypass Surgery (CABG) with their groundbreaking Elana Anastomotic System. This innovative, minimally invasive technology enables surgeons to create a sutureless bypass on a beating heart without using a heart-lung machine, thereby reducing patient impact and speeding up recovery.
As a Usability Engineer, you will take charge of leading human factors and usability engineering activities as part of the development of cutting-edge Class III implantable devices for heart bypass surgery. You will work closely with engineering partners and cross-functional teams to ensure that our products meet the highest standards of safety, efficacy, and quality.
You’ll report directly to Ruairi Duffy (Head of Design & Development).

Key Responsibilities:

• 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.

Profile

• 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.

Benefits

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.

Contact

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.