Process Development Engineer

Terumo Aortic; Renfrew; On-site; GBP 40,000 - 65,000; Full time

Job summary

Terumo Aortic is seeking a Process Development Engineer to support transferring new medical device products from R&D into manufacturing, ensuring design intent, quality and regulatory compliance are maintained through validation and production.

Working cross-functionally with R&D, Quality, Operations, Supply Chain and Regulatory teams, you will develop, validate and scale robust manufacturing processes, write documentation and drive process improvements for lifecycle success.

Qualifications

• Minimum of HND (or equivalent) in a relevant engineering discipline.
• Experience in a regulated manufacturing environment, preferably medical devices.
• Strong understanding of process design and industrialisation.

Responsibilities

• Support product transfer from development into manufacturing, ensuring process readiness and documentation.
• Develop, optimise 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.

Skills

Process design

Industrialisation

Process validation

Six Sigma

NPI/Design transfer

ISO 13485 / FDA QSR

Equipment development

Data-driven problem solving

Cross-functional collaboration

Education

HND or equivalent in engineering

Job description

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, optimise 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

What we’re looking for

• 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 industrialisation
• 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