Job Title

Location: Stonehouse, Gloucestershire, Gloucestershire, South West, UKProduct Engineer, Product DevelopmentLocationStonehouse, UKReporting ToManager of Product Development and DesignSupervisory ResponsibilityNoneJob ObjectiveThe 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 devicesPerform root cause analysis and establish FMEAs for injection-moulded componentsDefine product qualification protocols and acceptance criteria for functional testingCoordinate and execute validation test protocols in collaboration with internal stakeholdersWork closely with Operations and the tool shop to follow up on qualification activities for replacement injection moulds, including IQ, OQ, and PQ of existing partsEstablish quality control processes, including measurement instructions and inspection criteriaSupport the execution and implementation of Engineering Change RequestsPerson SpecificationQualifications and Experience Degree or equivalent qualification in Mechanical Engineering or a related discipline preferredPrevious experience in the design, construction, and injection moulding of disposable plastic devices is desirableExperience in project management and coordination of engineering tasksProficiency in CAD software, ideally CreoBasic working knowledge of SAPSkills and Competencies Willingness and ability to learn new skills and technologiesStrong communication and collaboration skillsProactive mindset with a structured problem-solving approachAbility to work independently while contributing effectively within a teamCapability to cooperate closely with Product Development, Product Management, Operations, and Quality teams across multiple sitesTPBN1_UKTJ