Usability Engineer

Unity Partners exclusively on behalf of our partner, AMT Medical

AMT Medical is a Class III medical device company that is transforming Coronary Artery Bypass Surgery (CABG) with their groundbreaking Elana Anastomotic System. Their minimally invasive technology enables surgeons to create a sutureless bypass on a beating heart without the use of a heart-lung machine, reducing patient impact and shortening recovery. AMT has finished patient inclusion of a large-scale clinical trial in 2024 and the results will become available in 2025. The offices are in Utrecht (Science Park) and in Ede. As AMT continues to grow, we are looking for a: Usability Engineer.

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 will 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.

Qualifications:

• 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).

• Familiarity with risk management (ISO 14971).

• 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.

Organization & Offer:

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

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