System Engineer Medical Devices

at  Enter Group

Locatie
Eindhoven
Dienstverband
40 uur per week
Does working on medical devices make your heart beat faster? And do you want to contribute to innovative hightech projects that help our customers build up a lasting lead in the world of technology? While at the same time you will be working for a company where you and your personal development are our priority? Then you are the candidate we are looking for!

WANT TO KNOW MORE?

Do you want to know more about what you’re going to do as System Engineer Medical Devices? Then contact Remco Sturkenboom via T: +31 6 21 44 77 47 or E: remco.sturkenboom@enter-group.nl

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 welldocumented and align with project goals and regulatory standards.