Senior Medical Device 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: Senior Medical Device Engineer.

As a Medical Device Design Engineer, you will take charge of designing and developing Class III medical devices from concept through to production scale-up. 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:

• Design and develop implantable Class III medical devices, ensuring innovative solutions from concept to production.
• Create detailed engineering models, drawings, and specifications using CAD software. This would only apply for people coming in with a background with CAD.
• Collaborate with cross-functional teams to define product requirements and ensure compliance with medical device regulations.
• Conduct feasibility studies, design experiments, and simulations to establish robust product specifications.
• Manage design verification and validation activities, including risk assessments throughout the product development lifecycle.
• Develop and execute test protocols, documenting outcomes to demonstrate device performance and regulatory compliance.
• Engage in design reviews, risk management sessions, and root cause analysis to optimize design.
• Provide technical support during the design transfer and production validation process, ensuring seamless manufacturing start-up.
• Remain abreast of industry trends, advancements, and regulatory changes that impact product design and compliance.

Qualifications:

• Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or related field.
• Minimum of 5 years’ experience in the full lifecycle development of Class III medical devices, ideally with a strong track record in the cardiovascular or implantable device sector.
• Proficient in 3D CAD software (e.g., SolidWorks, Fusion 360) and other engineering tools necessary for design and simulation. Not a must if you have a specialization on biocompatibility.
• Deep understanding of materials science as it applies to medical device manufacturing, including metals and polymers.
• Comprehensive knowledge of medical device regulatory standards (e.g., MDR, ISO 13485, ISO 14971, ISO 10993, FDA 21 CFR 820).
• Excellent problem-solving skills, attention to detail, and ability to manage multiple projects in a fast-paced environment.
• Fluent in English, with additional European languages being 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: AMT05032025/3 in all communications.

‍