Edwards Lifesciences Technologist - Advanced Catheters Pilot in Irvine, California
Edwards Lifesciences has a new opening for a Technologist – Advanced Catheters Pilot, supporting our Global Supply Chain - Irvine Pilot Operations. The mission of Irvine Pilot Operations is to enable Edwards to achieve rapid product development cycles coupled with exceptional product reliability, efficient cost, and real-time product transfers through a strong partnership with the NPD teams and the global plant network.
The Technologist will support engineering and validation activities related to establishing equipment capabilities, equipment procurement, IQ/OQ, process development, initial stabilization of new and in-sourced steerable catheter shafts for early human use as well as support equipment builds/repairs, preventative maintenance, and calibration activities. Additional objectives may include setting up and optimizing cleanroom configurations to improve quality and performance. This role will directly interact with the Advanced Catheter COE and other cross-functional engineering resources to support development and transfer of new processes and technologies to manufacturing.
Perform both scheduled and unscheduled preventive maintenance routines on a wider range of complex equipment to validate user operation and to avoid program down time.
Check for failures in complex equipment and processes and perform corrective actions to affected areas that have down time, including conducting and writing an impact assessment reports of incidents.
Be first responder to EH&S and or facilities issues related to Pilot MFG.
Troubleshoot and recommend maintenance 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.
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 in devising and implementing corrective actions, exception work orders (EWOs), Equipment Non-conformance Reports (ENCRs), and Out of Tolerance (OOTs).
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.
A High School Diploma or equivalent is required.
A minimum of 8 years of related experience is required; related experience includes working knowledge of electrical, mechanical, lubrication, pneumatic, boiler, autoclave, and/or HVAC system operations.
A completed trade school program in electric, mechanical, and/or electronics, including internship, is preferred.
Forklift certification desirable.
Knowledge of Good Manufacturing and Good Documentation Practices supporting a medical device environment.
Full knowledge of routine preventive maintenance of production equipment.
External training in system troubleshooting (e.g., electrical, mechanical, and/or electronics).
Strong written and verbal communication skills.
Good computer skills, including MS Office.
Ability to provide feedback in a professional, direct, and tactful manner.
Able to read, comprehend, speak, and write English.
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, and represent the organization to outside contacts, e.g., contractors, vendors, suppliers.
Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to the manufacturing floor operations and clean room medical device manufacturing.
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.