System Engineer Medical Devices

Over deze vacature

You will play a pivotal part in the development of two innovative projects in the field of Active Implantable Medical Device to improve the quality of life for patients with chronic conditions. You will collaborate with a highly skilled and motivated team of design engineers in a multicultural setting, working on different aspects of product development in the fields of electronics, embedded software, biocompatible encapsulation technologies and (pre-)clinical testing. Our multidisciplinary teams combine expertise from diverse domains to drive forward research and development for the next generation of implantable medical devices.

Job description

We need you as System Engineer with experience in the medical device industry to manage requirements, documentation, and verification activities in compliance with ISO13485, IEC60601 and IEC62304 standards. This role involves close collaboration with cross-functional teams to ensure that systems are designed, documented, and verified to meet regulatory requirements and high-quality standards for patient safety and effectiveness.

Your responsibility will be:

• Requirements Gathering & Analysis. Collaborate with cross-functional teams (software, hardware, clinical) to identify, document, and maintain system requirements. Translate customer and regulatory needs into functional specifications to guide the design and development process.
• System Architecture & Design. Contribute to define and manage system design and architecture, ensuring alignment with requirements. Work to ensure the system meets functional and nonfunctional needs, while supporting IEC62304 requirements throughout the software development lifecycle.
• Documentation & Compliance. Support the creation and maintenance of documentation, including requirements specifications, system architecture, and risk analyses, ensuring alignment with regulatory standards such as ISO13485 and IEC62304. Provide clear, compliant documentation accessible to engineering, manufacturing, and quality teams.
• Verification & Validation Activities. Take an active role in the verification process by developing test plans and protocols, supporting verification activities, and documenting results. Ensure that all system components meet specifications and regulatory requirements and that risk mitigation measures are effective.
• Strong understanding of quality management practices in medical device development, with an interest in playing an active role in improving the existing Quality Management System.
• Risk Management & Compliance. Familiarity with risk analyses according to ISO14971.
• Project Management & Communication. Coordinate cross-functional teams, oversee the project planning and act as a liaison between stakeholders, including HW & SW design, quality, and regulatory teams, to ensure that requirements, design, and verification activities are well-documented and align with project goals and regulatory standards.

Wat we van jou verwachten

• Bachelor’s or Master’s degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, or a related field.
• 3+ years of experience in a systems engineering role within the medical device industry, with exposure to IEC62304 and verification activities.
• Proven knowledge of regulatory standards (ISO13485, IEC62304, IEC60601, FDA CFR 21 Part 820) and risk management (ISO14971).
• Project management experience in leading multi-disciplinary teams, managing timelines, and overseeing the lifecycle of complex projects is highly valued.
• Experience in requirements management tools.
• Hands-on attitude, which means taking initiative, thinking pro-actively, having a flexible attitude and solving problems. 

Wat kun je van ons verwachten

At TMC we believe that people are the driving force behind technological innovation. That is why we want to create the best possible conditions for tech talents to thrive in. We offer you a challenging and stimulating work environment in which you can be the director of your own career.

As an Employeneur you are part of our TMC family. Next to our outstanding technical expertise, fun and engagement are meaningful parts of our culture.