Usability Engineer

1 week geleden

Utrecht, Utrecht, Nederland AMT Medical Voltijd
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. 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).

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.

• 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.

• MDR, 21CFR 820, ISO 13485) and quality management systems.

• Participate in design reviews, risk management, FMEA sessions, and root cause analyses as needed.

• 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.

• 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. AMT Medical offers a competitive salary and benefits package, along with substantial opportunities for professional growth and development.

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