Senior Engineering Technologist, Test Method Development

Edwards Lifesciences • Irvine, CA

1d • $70,000 - $99,000

About The Position

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Senior Engineering Technologist position is a unique career opportunity that could be your next step towards an exciting future. The Senior Engineering Technologist will support all TMTT 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. How you will make an impact : 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 Build complex prototypes, sub-assemblies, and prepare feasibility test units; may include making material recommendations Perform operational test and identify failure modes on systems and equipment and propose and implement technical solutions Design and build simple to complex fixtures or gages; using sketches, CAD, etc Perform test method development and validation for equipment and product designs May create and modify drawings and procedures for fixtures, equipment, products, components or processes 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 Receiving & Inspection and personnel in a cleanroom environment Collect, analyze, and document test data Order and maintain test lab/cleanroom supplies and equipment Initiate, assist and manage change management process for documentation and supplier changes through PLM and SQMS systems Other duties assigned by Management, including representing the department in corporate level initiatives.

Requirements

• Associate's Degree (or technical degree/certificate) with (8) years of experience in R&D Lab and/or medical device industry; OR (10) years of experience with engineering support, design, quality, manufacturing, or supporting with new product development
• Hands-on experience with Test Method Development
• Ability and willingness to travel up to 10%, primarily within the U.S., with occasional international travel as required

Nice To Haves

• Experience working within a regulated industry
• Test Method Development experience with programming and executing measurement routines using vision‑based inspection systems (e.g., Keyence, SmartScope, CMMs), to support dimensional inspection and routine measurements for development and production use.
• Hands‑on experience developing, executing, and validating inspection and test methods to support pilot and commercial product launches (Test Method Development/Validations).
• Strong practical experience with Gage R&R and measurement system analysis, including creating validation documentation and executing studies.
• Proven ability to design, build, and troubleshoot fixtures to support manual and automated inspection processes.
• Working knowledge of GD&T, with the ability to interpret drawings and apply tolerances appropriately within test method development; SolidWorks experience preferred.
• Strong documentation skills, including test protocols, work instructions, and and technical reports, with proficiency in MS Office.

Responsibilities

• 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
• Build complex prototypes, sub-assemblies, and prepare feasibility test units; may include making material recommendations
• Perform operational test and identify failure modes on systems and equipment and propose and implement technical solutions
• Design and build simple to complex fixtures or gages; using sketches, CAD, etc
• Perform test method development and validation for equipment and product designs
• May create and modify drawings and procedures for fixtures, equipment, products, components or processes
• 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 Receiving & Inspection and personnel in a cleanroom environment
• Collect, analyze, and document test data
• Order and maintain test lab/cleanroom supplies and equipment
• Initiate, assist and manage change management process for documentation and supplier changes through PLM and SQMS systems
• Other duties assigned by Management, including representing the department in corporate level initiatives.

Benefits

• Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree