Edwards Lifesciences Extrusion Maintenance Technologist in Irvine, California
The Extrusion Maintenance Technologist will provide technical support for preventive and unexpected in-process maintenance on Extrusion Equipment used in pre-commercial products to ensure ongoing optimum performance, compliance with EHS, and Good Manufacturing Practices to achieve equipment target uptime, product yield, and quality. Must also be able to extrude, single layer, 2 & 3 layer, multi-lumen thermoplastic tubing using a wide range of plastic materials. Will apply maintenance expertise and management of extrusion equipment to ensure ongoing optimum performance, in compliance with EHS and other applicable quality and regulatory guidelines.
• Manage and perform scheduled and unscheduled preventive maintenance routines for 3 extrusion lines including, vacuum sizing tanks, laser measurement systems, pullers, cutters, conveyors, resin dryers, cleaning furnaces, measurement microscopes and fixtures.
• Create scheduled maintenance plan based on manufacturers recommendations and implement plan into company network.
• Lead troubleshooting of equipment, perform enhancements, set up new equipment and be liaise and coordinate with vendors as required.
• Create tool crib for critical replacement components, extrusion tooling, and supplies
• Operate extrusion equipment including set-up, break down and running tubing as required to keep up with demand
• Provide training, coaching, guidance, and information to lower level technicians as requested and needed.
• Review, follow and perform check list actions for all equipment in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records.
• Troubleshoot and recommend maintenance to limit downtime, to keep production on schedule, and to ensure ongoing validation compliance.
• Collaborate with Quality in devising and implementing corrective actions, exception work orders (EWOs), Equipment Non-conformance Reports (ENCRs), and Out of Tolerance (OOTs).
• Assist in leading TPM, 5S, Lean Manufacturing and Continuous Improvement initiatives
• On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period
• Other duties as assigned by leadership (e.g. moving materials between sites and/or tubing deliveries)
• High School Graduate or equivalent
• 3+ plus years of professional experience in an extrusion environment
• Good communication skills
• Able to read, comprehend, speak, and write English
• Good computer skills, including MS Office
• Training in system troubleshooting (e.g., electrical, mechanical, and/or electronics) - from professional experience
• Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment
• Must be able to work independently and provide guidance and training to lower-level technicians
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
• Machining experience is a plus
• Maximo experience is a plus
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.