Job Summary
In the role of Product Engineer, you ensure product compliance and lifecycle integrity by owning design control and change control documentation for new and existing products. You translate regulatory requirements, standards and internal quality processes into clear, well‑structured documentation and actionable change records. Acting as a key interface between Regulatory Affairs, Quality and Engineering, you coordinate assessments, justification and approvals to ensure products remain compliant, traceable and audit‑ready throughout their lifecycle.
Job Responsibilities
1. Manage design control activities and ensure product development is executed and documented as planned
2. Own and coordinate change control processes, including modification sheets and stakeholder alignment
3. Define and oversee product testing strategies to assess performance and design adequacy
4. Define product characteristics, criticality, performance criteria, specifications and test methods
5. Build and document the technical and regulatory rationale behind design decisions
6. Evaluate product performance versus competitor products and existing Terumo portfolios
7. Provide technical data and insights on Terumo and competitor products to the business unit
8. Create and maintain Design History Files (DHF) and change control documentation
9. Coordinate documentation input across Engineering, QA, RA and other stakeholders
10. Participate in continuous improvement projects, analyzing issues and proposing compliant solutions from a product engineering perspective
Profile Description
11. Master’s degree in Engineering or equivalent experience
12. Strong affinity with design control, change control and regulated environments
13. Experience working closely with Regulatory Affairs and Quality is a strong plus
14. Solid project management, planning and stakeholder coordination skills
15. Strong communication and presentation skills, able to translate complex requirements clearly
16. Fluent in English, Dutch is a plus
17. Knowledge of Six Sigma, CAD tools, design software, AI or digital tools is an advantage
18. Proactive, pragmatic, stress‑resistant and accountable in follow‑up
Offer
19. A meaningful role at the intersection of Engineering, Quality and Regulatory Affairs, contributing directly to product compliance and patient safety
20. A warm and inclusive work environment where teamwork, trust, ownership and openness are valued, with regular team moments such as monthly afterwork gatherings
21. The opportunity to work at our Leuven site, recognized as Factory of the Future, with strong investment in people, technology and continuous improvement
22. A flexible, hybrid working model with approximately 3 days on site in Leuven
23. Opportunities to deepen your expertise in compliance, change management and medical devices within an international context
24. An attractive salary package, including meal vouchers, access to a subsidized company restaurant, pension plan, hospitalization and disability insurance, and a 24/7 Employee Assistance Program