Lead Quality Engineer – Advanced Catheters & Extrusions

Edwards Lifesciences; Irvine (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA seeks a Principal Quality Engineer to lead cross-functional Quality Engineering efforts across Advanced Catheters and Extrusions programs from development through commercialization.

You will apply TMV, IQ/OQ/PQ, material and design characterization, and statistical analysis to ensure robust product and manufacturing processes while guiding cross-site teams and technology transfer activities.

Qualifications

• Bachelor's degree in engineering or scientific related fields with a minimum of 6 years of experience in Quality Engineering, Manufacturing Quality, Process Engineering, or a related engineering discipline; OR Master's degree in engineering or scientific related fields with a minimum of 5 years of experience in these areas.
• Demonstrated experience with Test Method Validation (TMV) and process/equipment validation, including IQ/OQ/PQ.
• Highly regulated industry experience.

Responsibilities

• Serve as a Quality Engineering SME for Advanced Catheters and Extrusions programs through development, introduction, pilot manufacturing, and commercialization.
• Lead Quality Engineering activities for development and validation of products, processes, equipment, and test methods (TMV, IQ/OQ/PQ).
• Apply data-driven and statistical approaches to capability studies, data analysis, and validation results.
• Provide QC guidance for extrusion, polymer, catheter, and balloon technologies, including material properties and tolerances.
• Collaborate with R&D, Process Engineering, Manufacturing, Operations, and Supplier Quality to develop robust products and processes.
• Support manufacturing readiness, technology transfer, and commercialization across sites; author validation protocols/reports, specs, and risk docs.
• Lead investigations (nonconformances, CAPA, supplier issues) and mentor engineers/technicians to raise Q&R capability across programs.

Skills

Quality Engineering

Data analysis

Statistical methods

Cross-functional leadership

CAPA

Process validation

Education

Bachelor's degree in engineering or science

Master's degree in engineering or science

Job description

Edwards Lifesciences in Irvine, CA seeks a Principal Quality Engineer to lead cross-functional Quality Engineering efforts across Advanced Catheters and Extrusions programs from development through commercialization.

You will apply TMV, IQ/OQ/PQ, material and design characterization, and statistical analysis to ensure robust product and manufacturing processes while guiding cross-site teams and technology transfer activities.