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Associate Process Development Engineer

Terumo Aortic -
Inchinnan

Quick apply

Job details

Permanent
£33,000 - £35,000 a year
4 days ago

Qualifications

ERP systems
Communication skills
FDA regulations

Full job description

We are seeking an Associate Process Development Engineer to support the transfer of innovative medical device products from R&D into full-scale manufacturing. You will play a key role in ensuring that design intent, quality, regulatory compliance, and operational efficiency are maintained as products move into commercial production.

This is an excellent opportunity to join a collaborative manufacturing environment and contribute to the successful delivery of new product introductions within a regulated setting.

Key Responsibilities

Support the transfer of new products from development into manufacturing, ensuring readiness of processes, documentation and resources
Support the development and optimisation of manufacturing processes and work instructions
Contribute to Design for Manufacturability (DfM) activities early in the product lifecycle
Assist with development and execution of process validation strategies in line with regulatory standards
Support equipment qualification activities and ensure manufacturing capability meets requirements
Participate in risk analysis activities (e.g. PFMEA) and support mitigation actions
Support corrective and preventive actions during pilot builds and early production
Generate technical documentation including process specifications, validation protocols and reports
Collaborate with Quality Engineering to ensure compliance with QMS requirements
Work cross-functionally with R&D, Quality, Operations, Supply Chain and Regulatory teams
Support pilot builds and manufacturing scale-up activities
Partner with suppliers and external manufacturers where required

About You

Essential:

Experience in a regulated manufacturing environment (ideally medical devices)
Strong understanding of process design and manufacturing engineering principles
Knowledge of process validation, statistical methods and continuous improvement tools
Strong technical problem-solving capability
Excellent communication and stakeholder management skills
High attention to detail and disciplined approach to documentation
Ability to work effectively within cross-functional teams

Desirable:

Experience supporting new product introduction (NPI) or design transfer
Knowledge of ISO 13485 and FDA quality requirements
Familiarity with ERP systems or digital manufacturing tools
Exposure to Six Sigma or structured continuous improvement methodologies

Why Join us:

Be part of a globally recognised medical device organisation. Work on innovative products that make a real difference to patients. Collaborate with cross-functional teams in a supportive and dynamic environment. Develop your skills within a structured, highly regulated manufacturing setting.

Quick apply

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