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Medical Device Design Specialist
7 dagen geleden
About Us
At AMT Medical, we're pushing the boundaries of cardiac care with our innovative Elana Anastomotic System. This groundbreaking technology enables surgeons to create a sutureless bypass on a beating heart without using a heart-lung machine.
Job Description:
We're seeking a talented Medical Device Design Engineer to join our team. As a key member, you'll design and develop Class III medical devices from concept through to production scale-up. You'll work closely with engineering partners and cross-functional teams to ensure that our products meet the highest standards of safety, efficacy, and quality.
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.
Required Skills and 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.
What We Offer:
Join a dynamic scale-up poised to redefine cardiac care. Collaborate with a collaborative and flexible work environment where your contributions significantly impact patient outcomes. Based in Utrecht and Ede, we offer a competitive salary and benefits package, along with substantial opportunities for professional growth and leadership development.
