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We are recruiting a Process Development Engineer to support the successful transfer of new medical device products from R&D into full-scale manufacturing. This role plays a key part in ensuring design intent, quality, regulatory compliance and operational efficiency are maintained through validation and into commercial production.
Working cross-functionally with R&D, Quality, Operations, Supply Chain and Regulatory teams, you will help deliver robust, repeatable and scalable manufacturing processes within a highly regulated medical device environment.
Key responsibilities
1. Support product transfer from development into manufacturing, ensuring process, documentation and resource readiness
2. Develop, optimise and validate manufacturing processes, work instructions and processing methods
3. Support Design for Manufacturability (DfM) activities early in the product lifecycle
4. Develop and execute process validation strategies in line with regulatory standards FDA CFR, ISO )
5. Define and execute equipment qualification activities
6. Conduct risk management activities, including PFMEA, and drive mitigation actions
7. Lead root cause analysis and corrective/preventive actions during pilot builds and early production
8. Generate technical and regulatory documentation including validation protocols, reports and process specifications
9. Maintain audit readiness and ensure alignment with Quality Management System requirements
10. Support pilot builds, manufacturing scale-up and external supplier process development
11. Carry out additional duties in support of departmental and site objectives
What we’re looking for
12. Minimum of HND (or equivalent) in a relevant engineering discipline
13. Experience working in a regulated manufacturing environment, ideally medical devices
14. Strong understanding of process design and industrialisation
15. Experience with process validation, statistical methods and Six Sigma tools
16. Exposure to New Product Introduction (NPI) or design transfer activities
17. Working knowledge of ISO and FDA Quality System Regulations
18. Ability to develop process solutions including jigs, fixtures, tooling and equipment
19. Strong problem-solving capability with a structured, data-driven approach
20. Excellent communication skills and ability to work effectively in cross-functional teams
21. High attention to detail with disciplined documentation practices
22. Proactive, results-driven mindset with clear ownership of deliverables