Terumo Aortic
Process Development Engineer
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Process Development Engineer
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
- Support product transfer from development into manufacturing, ensuring process, documentation, and resource readiness
- Develop, optimize, and validate manufacturing processes, work instructions, and processing methods
- Support Design for Manufacturability (DfM) activities early in the product lifecycle
- Develop and execute process validation strategies in line with regulatory standards (e.g., FDA 21 CFR 820, ISO 13485)
- Define and execute equipment qualification activities
- Conduct risk management activities, including PFMEA, and drive mitigation actions
- Lead root cause analysis and corrective/preventive actions during pilot builds and early production
- Generate technical and regulatory documentation, including validation protocols, reports, and process specifications
- Maintain audit readiness and ensure alignment with Quality Management System requirements
- Support pilot builds, manufacturing scale-up, and external supplier process development
- Carry out additional duties in support of departmental and site objectives
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What we’re looking for
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- Minimum of HND (or equivalent) in a relevant engineering discipline
- Experience working in a regulated manufacturing environment, ideally medical devices
- Strong understanding of process design and industrialization
- Experience with process validation, statistical methods, and Six Sigma tools
- Exposure to New Product Introduction (NPI) or design transfer activities
- Working knowledge of ISO 13485 and FDA Quality System Regulations
- Ability to develop process solutions, including jigs, fixtures, tooling, and equipment
- Strong problem-solving capability with a structured, data-driven approach
- Excellent communication skills and ability to work effectively in cross-functional teams
- High attention to detail with disciplined documentation practices
- Proactive, results-driven mindset with clear ownership of deliverables
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