Senior Medical Device Engineer

3 weken geleden

Utrecht, Utrecht, Nederland AMT Medical Voltijd

Unity Partners exclusively on behalf of our partner, AMT Medical

We are actively seeking a Medical Device Design Engineer to join AMT Medical's innovative team. AMT aims to transform Coronary Artery Bypass Surgery (CABG) with their groundbreaking Elana Anastomotic System. This innovative, minimally invasive technology enables surgeons to create a sutureless bypass on a beating heart without using a heart-lung machine, thereby reducing patient impact and speeding up recovery.

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.

This role reports 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
  • 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, 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.

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