Product Engineer, Product Development Location Stonehouse, UK Reporting To Manager of Product Development and Design Supervisory Responsibility None Job Objective The Product Engineer will work collaboratively with Mechanical Engineers, Technicians, Product Management, Quality, and Operations teams to re-engineer and re-qualify single-use laboratory consumables used within the biopharmaceutical industry. The role focuses on ensuring product quality, compliance, and continuity through robust engineering and validation practices. Key Responsibilities Coordinate product engineering activities related to the requalification of injection-moulded plastic devices Perform root cause analysis and establish FMEAs for injection-moulded components Define product qualification protocols and acceptance criteria for functional testing Coordinate and execute validation test protocols in collaboration with internal stakeholders Work closely with Operations and the tool shop to follow up on qualification activities for replacement injection moulds, including IQ, OQ, and PQ of existing parts Establish quality control processes, including measurement instructions and inspection criteria Support the execution and implementation of Engineering Change Requests Person Specification Qualifications and Experience Degree or equivalent qualification in Mechanical Engineering or a related discipline preferred Previous experience in the design, construction, and injection moulding of disposable plastic devices is desirable Experience in project management and coordination of engineering tasks Proficiency in CAD software, ideally Creo Basic working knowledge of SAP Skills and Competencies Willingness and ability to learn new skills and technologies Strong communication and collaboration skills Proactive mindset with a structured problem-solving approach Ability to work independently while contributing effectively within a team Capability to cooperate closely with Product Development, Product Management, Operations, and Quality teams across multiple sites