Principal Engineer, NPD
Edwards Lifesciences · Irvine, CA
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Role summary
Edwards Lifesciences seeks a Principal Engineer to lead manufacturing process development for next-generation balloon expandable delivery systems in transcatheter heart valves. The role involves designing Class II/III medical device processes, executing validation strategies, scaling production across sites, and leading cross-functional teams. Requires a bachelor's degree in engineering with six years of experience, or a master's degree with five years, preferably in medical device manufacturing and NPD.
What they're looking for
- Bachelor's degree in engineering or scientific field with 6 years related experience, or Master's degree with 5 years related experience
- Medical device manufacturing operations and new product development experience
- Knowledge of catheter assembly processes including adhesive bonding, thermal bonding, tube flaring, coatings, and vision systems
- Understanding of mechanical systems, sensors, actuators, pneumatics, motors, controls, and machine safety
- cGMP and environmental health & safety compliance knowledge
- Design for manufacturability, Six Sigma, and LEAN methodologies
- Critical-to-quality design elements and process control establishment expertise
What you'll be doing
- Develop manufacturing processes for Class II/III medical devices with design controls and change management
- Design and execute experiments to establish process windows and improve manufacturing capability
- Lead validation strategies for equipment, software, processes, and manufacturing systems
- Develop scaling and replication approaches across manufacturing sites with comparability studies
- Lead cross-functional teams across R&D, manufacturing, quality, and suppliers to resolve technical challenges
Privacy & handoff
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