Edwards Lifesciences Senior Engineering Technician - Component Test Method Development & Validation / New Product Development (THV) in San Diego, California
The Senior Technician will support all THV new product development projects, focusing on test method development and validation for supplied components. This individual will work cross-functionally with R&D, Quality Engineering, Supplier Quality Engineering, Supplier Engineering, and Manufacturing to understand design requirements and intended use of components in the finished delivery system. This individual will work in a fast-paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success.
Support a wide range of engineering activities such as development of more complex tool, methods, and related validations for various measurement applications under minimal supervision of Engineers; and may propose technical solutions
Develop documentation and procedures in support of the inspection of components
Perform more complex work using statistical analysis such as capability, gage R&R, method comparison, and statistical process control
Support Pilot RI and personnel in a cleanroom environment
Collect, analyze, and document test data
Order and maintain test lab/cleanroom supplies and equipment
Conceptualization of gage and inspection fixture designs. Create prototypes and fixture designs of high complexity
Other duties assigned by Management, including representing the department in corporate level initiatives.
Minimum Education and Experience :
Associate's Degree or technical degree/certificate with (2) years of experience in R&D Lab and/or medical device industry; OR (4) years of experience with engineering support, design, quality, manufacturing, or supporting with new product development
Experience performing test methods associated with Gage R&Rs, validations, fixturing, and/or vision systems
Experience working within a highly regulated environment
Additional Skills & Preferred Experience :
Experience within medical device, pharma, biotech, food, automotive, or aerospace industries
Substantial knowledge of GD&T and Test Method Development best practices
Substantial experience with Solid Works
Substantial experience with 3D print design
Experienced with design for machining
Experienced in programming automated inspection vision systems of high complexity
Experienced with robotics
Experienced with complex system design and integration is preferred
Substantial understanding of inspection equipment in a lab environment
Ability to perform more complex troubleshooting
Good computer skills, including usage of MS Office Suite
Domestic and international travel, as needed. Expected less than 10% travel
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.