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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 xxuwjjq 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 SpecificationQua
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