At Terumo, we advance lifesaving medical technologies to benefit society. Are you eager to make a difference with us? Here, you’ll grow your expertise while staying true to your personal aspirations.
Guided by our Japanese heritage, we act with respect, take ownership, and pursue continuous improvement. If you see yourself in our values, keep reading; this might be the opportunity you're looking for.
Department Info
Within Terumo’s Pharmaceutical Solutions Division (PSD), we develop highly customized parenteral delivery solutions tailored to the specific needs, medicines and challenges of our pharmaceutical and medical device partners. PSD supports customers end‑to‑end, from early development through commercialization, with a strong focus on patient safety, quality and performance.
To enable this high level of customization, Terumo has invested heavily in flexible and highly automated production technologies. Our Leuven site is proudly recognized as a Factory of the Future, reflecting not only our advanced manufacturing environment, but also our people‑oriented culture and commitment to continuous improvement.
The Product Engineering team in Leuven operates at the intersection of Engineering, Quality and Regulatory Affairs. The team plays a key role in design control, change control and product lifecycle management, ensuring products remain compliant, well‑documented and audit‑ready throughout their lifecycle. Collaboration, compliance and pragmatism go hand in hand in an open and supportive team culture built on trust, ownership and close stakeholder interaction.
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
- Manage design control activities and ensure product development is executed and documented as planned
- Own and coordinate change control processes, including modification sheets and stakeholder alignment
- Define and oversee product testing strategies to assess performance and design adequacy
- Define product characteristics, criticality, performance criteria, specifications and test methods
- Build and document the technical and regulatory rationale behind design decisions
- Evaluate product performance versus competitor products and existing Terumo portfolios
- Provide technical data and insights on Terumo and competitor products to the business unit
- Create and maintain Design History Files (DHF) and change control documentation
- Coordinate documentation input across Engineering, QA, RA and other stakeholders
- Participate in continuous improvement projects, analyzing issues and proposing compliant solutions from a product engineering perspective
Profile Description
- Master’s degree in Engineering or equivalent experience
- 3 to 5 years of experience within the life sciences or medical device sector
- Strong affinity with design control, change control and regulated environments
- Experience working closely with Regulatory Affairs and Quality is a strong plus
- Solid project management, planning and stakeholder coordination skills
- Strong communication and presentation skills, able to translate complex requirements clearly
- Fluent in English, Dutch is a plus
- Knowledge of Six Sigma, CAD tools, design software, AI or digital tools is an advantage
- Proactive, pragmatic, stress‑resistant and accountable in follow‑up
Offer
- A meaningful role at the intersection of Engineering, Quality and Regulatory Affairs, contributing directly to product compliance and patient safety
- A warm and inclusive work environment where teamwork, trust, ownership and openness are valued, with regular team moments such as monthly afterwork gatherings
- The opportunity to work at our Leuven site, recognized as Factory of the Future, with strong investment in people, technology and continuous improvement
- A flexible, hybrid working model with approximately 3 days on site in Leuven
- Opportunities to deepen your expertise in compliance, change management and medical devices within an international context
- 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
Contact Person
Marjolein Buyl - Talent Acquisition Business Partner
Working at Terumo means advancing healthcare with heart. Here, you are empowered to grow your own way, inspired to create to innovate, and supported as we get there together. Join us in shaping a healthier future for our patients, society, and each other.
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