Principal Quality Engineer, Advanced Catheters & Extrusions

Edwards Lifesciences • Irvine, CA

12d • $121,000 - $171,000

About The Position

The Principal Quality Engineer serves as a Quality Engineering technical subject matter expert supporting Advanced Catheters and Extrusions Process Engineering programs from early-stage development through commercialization. This highly cross-functional role partners with R&D, Process Engineering, Manufacturing, Operations, Supplier Quality, and other Quality teams across multiple sites to provide technical leadership for new product development, new product introduction, pilot manufacturing, and technology transfer.

The role 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 to support robust products and manufacturing processes. It also provides technical guidance for complex product, process, and Quality investigations and supports validation, manufacturing readiness, and commercialization activities.

The position requires a bachelor’s degree in an engineering or scientific-related field with at least six years of relevant experience, or a master’s degree in such a field with at least five years of relevant experience, as well as demonstrated experience with TMV and process/equipment validation in a highly regulated industry. Medical device, catheter, extrusion, polymer, and related experience is preferred.

For California, the base pay range is $121,000 to $171,000 for highly experienced candidates. Pay depends on qualifications, education, and prior experience. Applications are accepted while the position is posted on the Careers website.

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 engineering or a scientific-related field and at least 5 years of experience in these areas.
• 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 catheters, balloons, 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 understanding 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 within 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 a Quality Engineering technical subject matter expert for Advanced Catheters and Extrusions programs throughout new product development, new product introduction, pilot manufacturing, and commercialization.
• Lead Quality Engineering activities for the development and validation of products, manufacturing processes, equipment, and test methods, including TMV and IQ/OQ/PQ activities.
• Apply data-driven and statistical approaches to Quality Engineering decisions, including capability studies, data analysis, experimental results, and assessments of process and product performance.
• Provide Quality Engineering expertise for extrusion, polymer, catheter, and balloon-related technologies, evaluating material properties, design requirements, tolerances, specifications, and associated 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 to support manufacturing readiness, validation, technology transfer, and commercialization.
• Develop, review, and approve technical documentation, including 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.
• Provide technical mentorship and guidance to 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 the diverse individual needs of employees and their families

What This Job Offers

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