Sr. Systems Engineer

• System Architecture & Design: Translate complex user needs into robust system requirements and high-level designs for both new product introductions (NPI) and legacy enhancements.
• Technical Leadership: Lead cross-functional teams and serve as the technical "right hand" to Project Managers to drive the release of integrated IGT and 3rd party solutions.
• Strategic Roadmap Support: Influence the evolution of our product portfolio by aligning technical possibilities with clinical and business roadmaps.
• Quality & Compliance: Drive excellence in medical device quality processes, including risk management, post-market surveillance, and regulatory adherence.
• Practice Innovation: Actively evolve our Systems Engineering methodologies (e.g., MBSE) to keep our development engine world-class.

To succeed in this role, you should have the following skills and experience

• Master's Degree in an Engineering discipline (e.g., Systems, Software, or Mechatronics) with 10+ years of industry experience, with at least 5+ years in a technical leadership role within a regulated environment (Medical, Aerospace, or Automotive).
• Proven experience in executing pre-market and post-market risk assessments (e.g., FMEA, ISO 14971) to ensure patient and operator safety.
• Deep "hands-on" experience in both Requirement Design (translating clinical needs to specs) and Requirement Management (traceability and lifecycle tools).
• Strong ability to use DFSS (Design for Six Sigma) and Reliability Engineering tools to optimize complex system performance.
• Experience with Model-Based Systems Engineering (MBSE) and SysML is highly preferred.
• Familiarity with medical device standards (e.g., IEC 60601) and global regulatory requirements.

70.000 tot 90.000 32 - 40 uur nieuw Status Open

We are looking for a Systems Engineer for our market-leading Azurion and Allura platforms. In this role, you will bridge the gap between complex engineering and life-saving clinical outcomes, ensuring our Image Guided Therapy solutions remain the gold standard for minimally invasive diagnosis and treatment. Our Challenge We are on a mission to improve global health through precision and reliability. Our systems support physicians in high-stakes environments-from cardiovascular interventions to neurosurgery. Your challenge is to balance the rapid delivery of innovative clinical features with the rigorous demands of life-cycle management and global sustainability for a massive installed base. Your Team You will join a global Center of Excellence consisting of 27 elite professionals across the Netherlands, India, and China. This is a community of experts where deep technical knowledge meets collaborative leadership. You won't just be managing requirements; you'll be shaping the future of how complex medical systems are architected and maintained.