Principal Quality Engineer, Advanced Catheters & Extrusions

Edwards Lifesciences • Irvine, CA

11d

About The Position

The Principal Quality Engineer serves as a Quality Engineering technical subject matter expert for Advanced Catheters and Extrusions Process Engineering programs, from early-stage development through commercialization. The role provides technical leadership for new product development, new product introduction, pilot manufacturing, and technology transfer, in partnership with R&D, Process Engineering, Manufacturing, Operations, and Quality teams across multiple sites.

The engineer applies Quality Engineering expertise to test method validation; process and equipment validation (IQ/OQ/PQ); material and design characterization; tolerancing; capability studies; and statistical analysis. The role supports robust product and manufacturing processes and contributes to manufacturing readiness, validation, technology transfer, and commercialization. It also develops, reviews, and approves technical documentation and provides guidance on complex product, process, and Quality investigations. The position includes technical mentorship of engineers and technicians.

Requirements

• Bachelor's degree in engineering or a scientific-related field and at least 6 years of experience in Quality Engineering, Manufacturing Quality, Process Engineering, or a related engineering discipline; or a master's degree in one of these fields and at least 5 years of relevant experience.
• Demonstrated experience with Test Method Validation (TMV) and process/equipment validation, including IQ/OQ/PQ.
• Experience in a highly regulated industry.

Nice To Haves

• Medical device industry experience supporting Class II and/or Class III products.
• Experience with extrusion and/or polymer manufacturing processes, including material property testing and analysis.
• Experience supporting catheter, balloon, extrusion, or other polymer-based medical-device technologies.
• Experience with technology transfer and supporting products or manufacturing processes from development through pilot production, validation, manufacturing readiness, and commercialization.
• Knowledge of or experience with Product Development Process (PDP), Design Controls, and risk management.
• Experience with material- and design-related characterization, including specifications and tolerancing.
• Experience leading cross-functional technical teams or projects and partnering across multiple sites.
• Project management experience supporting complex product development or manufacturing programs.
• Experience applying statistical methods to capability studies, validation activities, and technical decision-making.
• Experience providing Quality Engineering support in a development, pilot manufacturing, laboratory, or Center of Excellence environment.
• Certified Quality Engineer (CQE), Six Sigma Black Belt, Lean Black Belt, or related certification.

Responsibilities

• Serve as the Quality Engineering technical subject matter expert for Advanced Catheters and Extrusions programs throughout product development, introduction, pilot manufacturing, and commercialization.
• Lead Quality Engineering activities for product, manufacturing process, equipment, and test method development and validation, including TMV and IQ/OQ/PQ.
• Use statistical and data-driven methods, including capability studies and data analysis, to evaluate process and product performance and inform Quality Engineering decisions.
• Provide expertise on extrusion, polymer, catheter, and balloon-related technologies, including material properties, design requirements, tolerances, specifications, and product and manufacturing risks.
• Partner with R&D, Process Engineering, Manufacturing, Operations, Supplier Quality, and other Quality teams to develop robust products and manufacturing processes and support program execution.
• Collaborate across sites and with technical centers of excellence on manufacturing readiness, validation, technology transfer, and commercialization.
• Develop, review, and approve validation protocols and reports, specifications, test methods, risk-management documentation, process controls, and change-control documentation.
• Lead and provide technical guidance for complex product, process, and Quality investigations, including nonconformances, CAPA, supplier quality issues, and other Quality or compliance matters.
• Mentor and guide engineers and technicians to build Quality Engineering capability and consistency across programs.
• Perform other incidental duties.

Benefits

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

What This Job Offers

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