Medical Device Engineer – Autoinjectors & Risk Management | Belgium

I’m currently supporting a leading pharmaceutical organisation in Belgium with the search for an experienced Medical Device Engineer to join a Devices, Artwork & Packaging team.

This is an exciting opportunity for someone with strong autoinjector and combination product experience who enjoys working at the intersection of device engineering, risk management, technical documentation and cross-functional development.

The Role

You’ll support cross-functional technical teams working across the design, development, industrialisation and lifecycle management of drug-device combination products, with a particular focus on autoinjectors and safety syringes.

A major part of the role will involve authoring, maintaining and reviewing high-quality risk management documentation, ensuring technical accuracy, traceability and regulatory compliance throughout the product lifecycle.

Key Responsibilities

- Author and maintain Risk Management Plans, Risk Analyses, Risk Evaluation Records and Risk Management Reports
- Work with FMEA, hazard analysis, use-related risk analysis and risk-control traceability
- Ensure alignment between hazards, harms, risk controls, verification evidence and residual-risk conclusions
- Conduct detailed consistency, completeness and traceability reviews across technical documentation
- Identify documentation gaps and discrepancies that could impact design reviews, regulatory submissions or audits




- Collaborate with Device, Quality, Safety, Regulatory and Human Factors stakeholders
- Coordinate technical documentation reviews and drive resolution of comments and actions
- Support Benefit-Risk Board documentation and technical gap assessments
- Contribute to improving and harmonising risk-management processes, templates and working practices

What we're looking for

- Bachelor's or Master's degree in Engineering, Life Sciences, Pharmaceutical Sciences, Technical Writing or a related discipline
- 8–15 years' experience within medical devices, combination products, pharmaceuticals or regulated technical documentation
- Proven autoinjector development experience – essential
- Strong hands-on experience with medical-device risk management documentation
- Good knowledge of ISO 14971 and design controls
- Experience with FMEA, hazard analysis, risk controls and traceability
- Understanding of EU MDR, Article 117, GSPR, 21 CFR Part 820, 21 CFR Part 4, ISO 13485 and GMP
- Excellent technical writing, editing and document-structuring skills
- Strong attention to detail and ability to translate complex technical information into clear, inspection-ready documentation
- Confident working with cross-functional technical and regulatory stakeholders

If you have strong autoinjector + ISO 14971 + combination product risk-management experience and would be interested in hearing more, please get in touch.

📌 Medical device engineer (España)
🏢 Planet Pharma
📍 España