Edwards Lifesciences Sr. Technician, THV NPD in Irvine, California
We are looking for a Sr. Technician for Edwards Lifesciences' New Product Development (NPD) team to support Transcatheter Heart Valve (THV) projects. This team is responsible for the development of manufacturing and inspection processes for new products (delivery system, sheath, and accessories). The Sr. Technician will work closely with NPD engineers and cross-functional team members to support development of future devices.
Essential job functions:
Support a wide range of engineering activities such as testing, troubleshooting, equipment/tooling induction and qualification, data collection and documentation, purchasing, and assembly under minimal supervision of Engineers. May propose technical solutions. Perform more complex work using drawings, diagrams, written and verbal instructions, layouts or defined plans.
Perform somewhat complex troubleshooting of standard and custom equipment to identify root causes; propose and implement temporary and/or permanent solutions in collaboration with Engineers.
Perform operational tests and identify failure modes on systems and equipment; identify and propose best test and measurement methods for equipment or product testing in collaboration with Engineers; may propose technical solutions.
Induct new equipment in Maximo and set up associated preventive maintenance procedures.
Draft and execute Tooling and Fixture Installation Qualifications and Installation Qualifications.
Make tooling, equipment, and supplies purchases.
Other incidental duties as assigned by Management.
Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to lab and/or clean room medical device manufacturing.
Perform other duties and responsibilities as assigned.
Associate degree or equivalent technical degree/certificate.
2 years previous experience in R&D Lab or Manufacturing.
Medical device experience is preferred.
Basic written and verbal communication skills.
Good interpersonal and relationship building skills.
Good computer skills, including usage of MS Office Suite.
Use of GDP (Good Documentation Practices).
Substantial understanding of equipment in a lab environment; Ability to use a wider range of manufacturing, test, development or diagnostic equipment.
Ability to perform somewhat complex troubleshooting.
Ability to identify problems and relevant issues in straightforward and somewhat complex situations
Ability to read and understand procedures, drawings, schematics and carry out assembly instructions.
Strict attention to detail.
Must be able to work in a team environment, including inter-departmental teams.
Ability to provide feedback in a professional, direct, and tactful manner.
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.