Edwards Lifesciences Sr. Tech, Quality - Transcatheter Mitral and Tricuspid Therapies in Irvine, California
Have you been searching for a role that brings you to the forefront of innovation? We have an outstanding leadership opportunity for you to join an early-stage medical device team boldly designing transcatheter mitral and tricuspid therapies from the ground up! The Transcatheter Mitral and Tricuspid Therapies (TMTT) division is passionate about developing breakthrough solutions for patients suffering from structural heart disease. Join this rapidly growing, fast paced, dynamic team as a Sr Quality Technician and play a pivotal role in bringing new medical devices to commercialization.
• Support investigation of complex product quality and compliance issues reported from the field to determine root cause/probable cause
• Support development and perform execution of moderately complex experiments and tests (including writing and executing protocols) to investigate issues and improve products and manufacturing methods based on engineering principles; analyze results, make recommendations, and develop reports , and initiate and review reports.
• Perform device history record (DHR) reviews to support complaint investigations
• Support a wider range of engineering activities such as test, modification, fabrication and assembly under minimal supervision of Engineers; and may propose technical solutions. Perform more complex work using drawings, diagrams, written and verbal instructions to perform testing, and trouble-shooting functions
• Operate a wider range of lab equipment including set-up, clean-up, break-down, and re-assembly Perform operational test and identify failure modes on systems and equipment; may propose technical solutions
• Collect and document test data
• Order and maintain lab supplies and equipment
• Other incidental duties as assigned by Management
Education and Minimum Requirements:
Associate's Degree or technical degree/certificate and 2 years of R&D Lab and/or medical device technician experience; OR
4 years of experience in R&D Lab and/or medical device technician (without degree)
Quality or R&D engineering support experience in the manufacturing of class III medical devices
Additional Talents and General Expectations:
• Strong written and verbal communication, organizational, interpersonal, and relationship building skills
• Problem solving methodology, root cause analysis, critical thinking, and GDP (Good Documentation Practices)
• Strong computer skills, including usage of MS Office Suite
• Substantial understanding of equipment in a lab environment
• Ability to perform more complex troubleshooting
• Ability to identify problems and relevant issues in straightforward and more complex situations, assessing using standard procedures
• Ability to use a wider range of manufacturing, test, development or diagnostic equipment; use tools such measuring equipment
• Ability to read and understand procedures, drawings, schematics and carry out assembly instructions
• 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
• 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
• 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
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.