Kevin Bacon

Injection Moulding Tooling Specialist Process Validation Engineer @Europlaz Technologies Ltd

Southminster, GB

Tool Development: • Collaborate with product designers and manufacturing teams to ensure tools meet design specifications and production requirements.• Process Validation:• Conduct validation studies (IQ, OQ, PQ) to ensure that the injection moulding processes are compliant with regulatory standards such as ISO 13485, FDA, and GMP.• Develop and implement validation protocols to verify that the manufacturing process consistently produces devices that meet predefined acceptance criteria.• Utilize statistical process control (SPC) tools to monitor process capability and variability, ensuring continuous improvement in quality.• Troubleshooting and Optimization:• Diagnose and resolve issues related to tooling, material defects, and process inefficiencies.• Implement modifications to tooling or process parameters to enhance yield, reduce cycle time, and improve part quality.• Documentation and Compliance:• Maintain meticulous records of all validation activities, test results, and adjustments made to tools or processes.• Ensure all documentation is compliant with industry standards and ready for regulatory audits.• Conduct material testing to ensure compatibility with the injection moulding process and the final medical application.• Team Collaboration and Training:• Work closely with cross-functional teams including design, quality assurance, production, and regulatory affairs.• Train production staff on new processes or tools to ensure effective implementation and sustained operation.• Project Management:• Lead or support projects aimed at new product development or process improvements in injection moulding.• Innovation and Continuous Improvement:• Stay updated with the latest in injection moulding technology, materials science, and medical device regulations to drive innovation.• Participate in or lead initiatives for continuous process improvement.