Medical Device Engineer

Join AMT Medical and Help Transform Cardiac Surgery 

Who We Are 

AMT Medical B.V. is a Dutch medical technology company developing the ELANA® Anastomotic System
for coronary artery bypass surgery. Founded on technology pioneered at UMC Utrecht for
neurovascular bypass surgery and brought to market under CE and FDA approvals by the original
ELANA team, AMT Medical is headquartered in Ede with laboratory facilities in Utrecht, The
Netherlands. The company is ISO 13485-certified and holds more than 40 patents. AMT Medical
collaborates with leading cardiac surgery centers in The Netherlands, with Charité –
Universitätsmedizin Berlin in Germany, and is building relationships with leading academic centers in
the United States, supported by an international network of cardiothoracic surgery and cardiology key
opinion leaders.

Why Join AMT Medical? 

• ∙Work on innovative medical technology that has the potential to transform cardiac surgery. 
• ∙Join a fast-growing company where your ideas, expertise, and initiative truly make a difference. 
• ∙Be part of a passionate, multidisciplinary team dedicated to improving patients’ lives.

The Role 

The medical device engineer is essential to ensuring that AMT Medical’s highrisk, lifesupporting
implantable devices are conceived, designed, verified, validated, manufactured, and maintained so that
they are safe, effective, and compliant to international regulatory requirements for Medical device
development.

What You will Do 

As a Medical Device Engineer, you will play a key role in the development of innovative Class III implantable medical devices. Working closely with multidisciplinary teams, you will contribute to every stage of the product lifecycle, from concept and design through verification, validation, and manufacturing.

• Design and develop implantable Class III medical devices, from concept through production 
  scale-up.  
• Create detailed engineering models, drawings, and technical specifications using CAD and 
  other engineering tools.  
• Collaborate with multidisciplinary teams to translate user needs into innovative and compliant 
  product designs.  
• Plan and execute feasibility studies, design verification and validation activities, and analyze 
  test results.  
• Perform risk assessments and contribute to design reviews, FMEA, and root cause 
  investigations.  
• Ensure compliance with applicable medical device regulations and quality standards (e.g. 
  MDR, ISO 13485, 21 CFR Part 820).  
• Support design transfer, manufacturing, and production validation, working closely with 
  manufacturing and external suppliers.  
• Lead technical activities within development projects and mentor colleagues to strengthen the 
  team’s engineering capabilities.

Who You Are 

• Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, Industrial 
  Engineering, or a related technical discipline.  
• Minimum 5 years of hands-on experience in the design, development, and verification & 
  validation (V&V) of medical devices, preferably Class III and/or implantable devices.  
• Proven experience across the full medical device development lifecycle, from concept 
  development through design transfer and production scale-up.  
• Strong knowledge of medical device regulations and standards, including MDR, ISO 13485, ISO 
  14971, ISO 10993, and FDA 21 CFR Part 820.  
• Experience developing and executing design verification activities, including test method 
  validation (TMV) and verification testing for implantable medical devices.  
• Experience with engineering materials used in implantable and delivery devices, including 
  metals and polymers.  
• Experience working with external suppliers and Contract Manufacturing Organizations (CMOs).  
• Experience preparing technical documentation and reports to support design history files, 
  regulatory submissions, and product development activities.

Skills & Competencies 

• Strong understanding of the medical device development lifecycle, design control, and 
  engineering best practices.  
• Solid knowledge of medical device regulations, standards, and quality management systems, 
  including MDR, ISO 13485, ISO 14971, ISO 10993, and FDA 21 CFR Part 820.  
• Expertise in design verification and validation (V&V), including Test Method Validation (TMV) 
  and verification testing for implantable medical devices.  
• Strong understanding of engineering materials and manufacturing processes for implantable 
  and delivery devices, including metals and polymers.  
• Proficiency in statistical analysis and data interpretation to support engineering decisions and 
  product development.  
• Excellent technical writing skills, with the ability to prepare clear and accurate engineering 
  documentation and technical reports.  
• Strong analytical and problem-solving skills, with a structured and detail-oriented approach.  
• Excellent communication and collaboration skills, with the ability to work effectively in 
  multidisciplinary teams and with external partners.  
• Proactive, hands-on, and results-oriented, with the ability to take ownership and drive 
  technical activities.  
• Fluent in English, both written and spoken.

What We Offer 

• Contribute to technology that has the potential to improve patients’ lives worldwide.  
• Personal and professional development opportunities.  
• Gross monthly salary of € 4,200–€5,800 (full-time), depending on experience.  
• 25 vacation days plus the day after Ascension Day as an additional paid company holiday.  
• Competitive pension plan.  
• Travel reimbursement.  
• Annual Sports and Wellbeing Allowance.  
• An open, collaborative working environment.

Interested? 

If this opportunity matches your experience and ambitions, we encourage you to apply. Please submit your application and resume using the contact form below.
If you have any questions about the role or the application process, please feel free to contact us by email at Nicole.vandervis@amt-medical.nl.