Principal Engineer, Supplier Development

Edwards Lifesciences • Irvine, CA

3d • Onsite

About The Position

The Principal Engineer serves as a technical subject matter expert for Surgical Therapies, partnering with internal teams and external suppliers to ensure product designs meet user needs, including ease of use, manufacturability, cost effectiveness, and operational efficiency. The role combines deep technical leadership with project management and a thorough understanding of Design Control and Catalyst processes to support effective, compliant, and timely project execution.

The engineer leads supplier technical validation throughout product development, from component design and GD&T reviews through process characterization, capability analysis, and strategic process validation. The role also supports next-generation delivery system and component design, leads cross-functional development and testing of complex interventional catheter delivery systems for implantable devices, and drives timelines for feasibility studies, design verification testing, clinical evaluations, and supplier validation activities required for commercial release. On-site work is required, with travel up to 25% domestically and internationally.

Requirements

• Bachelor's degree in engineering or a scientific field.
• Six years of experience in new product development, process development, commercialization, and/or operations engineering in a highly regulated environment.
• Travel up to 25% domestically and internationally.
• On-site work required.

Nice To Haves

• Master’s degree in engineering and/or MBA.
• Experience in medical device new product development, including successful design optimization and progression from early development through commercialization.
• Background in at least two of the following areas: interventional access devices, rapid product development, component-level manufacturing, or complex assembly design.
• Hands-on experience with catheter manufacturing processes, such as extrusions, braiding, molding, laser welding, and bonding techniques.
• Capability to apply sound engineering judgment and technical expertise to solve complex problems.
• Working knowledge of DFM, GD&T, and Six Sigma methodologies.
• Technical skills in biomedical design and delivery system catheter design.
• Proven ability to manage and collaborate with external vendors to meet quality, timeline, and technical requirements.
• Strong experience in rapid product development within cross-functional teams, including creative design iteration, prototyping, and test method development (e.g., in-vitro testing).

Responsibilities

• Lead end-to-end technical validation of suppliers during product development, including component design and GD&T reviews, process characterization, capability analysis, and strategic process validation.
• Ensure robust DFM/DFA integration and quality compliance across all development stages.
• Build and maintain partnerships with R&D, Program Management, Manufacturing, Supplier Quality, and key suppliers to support project execution and compliance with internal procedures, QSR, FDA regulations, and ISO standards.
• Support product development by influencing the design and iteration of next-generation delivery systems and components.
• Lead cross-functional teams and external suppliers in the design, development, and testing of complex interventional catheter delivery systems for implantable devices.
• Oversee and drive timelines for feasibility studies, design verification testing, clinical evaluations, and supplier validation activities required for commercial release.
• Perform other duties and responsibilities as assigned.

Benefits

• Competitive salaries
• Performance-based incentives
• A wide variety of benefits programs to address the diverse individual needs of employees and their families

What This Job Offers

• Job Type: Full-time
• Career Level: Principal