Principal Engineer, Surgical Delivery & Supplier Development

Edwards; Irvine (CA); On-site; USD 121,000 - 171,000; Full time

Job summary

Edwards Lifesciences (California) seeks a Principal Engineer to lead supplier validation and DFM/DFA-driven product development for surgical delivery systems. You will collaborate with R&D, manufacturing, and external vendors to ensure performance, quality, and timely delivery in a highly regulated setting.

The role requires a strong technical background in catheter delivery technologies and experience driving design controls, risk management, and verification testing across development stages.

Qualifications

• Bachelor's degree in engineering or scientific with 6 years of experience in NPD, process development, commercialization, or operations engineering in a highly regulated environment.
• Master's degree in engineering and/or MBA is advantageous.
• Experience in medical device NPD and rapid development is preferred.

Responsibilities

• Lead end-to-end technical validation of suppliers during product development, including component design, GD&T reviews, process characterization, capability analysis, and process validation.
• Build partnerships with R&D, Program Management, Manufacturing, Supplier Quality, and key suppliers to ensure compliant project execution.
• Influence design and iteration of next-generation delivery systems and components.
• Lead cross-functional teams and external suppliers in designing, developing, and testing complex interventional catheter delivery systems.
• Oversee timelines for feasibility studies, design verification, clinical evaluations, and supplier validation for commercial release.

Skills

Project management

Design controls

GD&T

Six Sigma

Vendor management

Education

Bachelor's degree in engineering or sciences

Master's degree in engineering and/or MBA

Job description

Edwards Lifesciences (California) seeks a Principal Engineer to lead supplier validation and DFM/DFA-driven product development for surgical delivery systems. You will collaborate with R&D, manufacturing, and external vendors to ensure performance, quality, and timely delivery in a highly regulated setting.

The role requires a strong technical background in catheter delivery technologies and experience driving design controls, risk management, and verification testing across development stages.