Medical Device Design Engineer

• Design and develop implantable Class III medical devices, ensuring innovative solutions from concept to production. 
• Create detailed engineering models, drawings, and specifications.  
• 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. 

• 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, with a strong track record in the cardiovascular or implantable device sector. 
• Proficient in 3D CAD software (e.g., SolidWorks, Fusion 360 or similar) and other engineering tools necessary for design and simulation. 
• Deep understanding of materials science as it applies to biosafety and 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 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: AMT05032025/3 in all communications.