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
* 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.
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