Associate Process Development Engineer

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
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• 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

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

• 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

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.

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