Edwards Lifesciences Technologist, Maintenance – 3rd Shift in Irvine, California
Hours are Wednesday to Sunday 11PM to 7:30AM.
Applies skill in the preventive and unexpected in-process maintenance of production equipment for commercial products and equipment used in pre-commercial products to ensure ongoing optimum performance, in compliance with EHS, Good Manufacturing and Good Documentation Practices, and other applicable quality and regulatory guidelines associated with medical device manufacturing.
Essential job functions:
Perform primarily unscheduled preventive maintenance routines on a wider range of complex equipment to validate user operation and to avoid program down time, including providing expertise and guidance in resolving complex failures.
Check for failures in more complex in equipment and processes, and perform corrective actions to affected areas that have down time, including conducting and writing an impact assessment reports of incidents exception work orders (EWOs), Equipment Non-conformance Reports (ENCRs), and Out of Tolerance (OOTs).
Troubleshoot as well as anticipate issues, and propose solutions to limit downtime, to keep production on schedule, and to ensure ongoing validation compliance.
Apply knowledge of processes in the use of machines to ensure successful outcomes, as well as to devise complex process changes, and ensure knowledge transfer to other levels of technicians.
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 and entering information into CMMS (Computerized Maintenance Management System).
Collaborate with Quality and Engineering to evaluate existing processes and identify opportunities for improvement and optimal operations.
Provide training, coaching, guidance, and information as requested and needed.
On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period.
Perform other duties and responsibilities as assigned.
- High School Diploma or equivalent with 8 years of demonstrated ability to lead teams, coach others, and transfer knowledge with related experience; working knowledge of electrical, mechanical, lubrication, pneumatic, boiler, autoclave, and/or HVAC system operations. Or, Associates Degree or equivalent with trade school program in electric, mechanical, and/or electronics, including internship.
Extensive knowledge of routine preventive maintenance of production equipment.
Certified in multidisciplinary electrical, mechanical, electronic, pneumatic, and controls.
Strong English language skills, including reading, comprehending, speaking and writing, and good communication skills.
Ability to provide feedback in a professional, direct, and tactful manner.
Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to the manufacturing floor operations and clean room medical device manufacturing.
Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment.
Must be able to work with minimum supervision by following detailed maintenance instructions, and provide guidance and training to lower-level technicians.
Work in an inter-departmental team environment, as well as with colleagues from other departments, in the exchange and advancement of information and represent the organization to outside contacts, e.g., contractors, vendors, suppliers.
Proficient computer skills, including MS Office.
Good communication skills.
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 13,000 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.