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.