Lead Quality Engineer - Advanced Catheters & Extrusions

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

Job summary

Edwards Lifesciences is seeking a Principal Quality Engineer to support Advanced Catheters and Extrusions from early development to commercialization. You will partner with R&D, Process Engineering, Manufacturing, and Operations to drive quality decisions across multiple sites and ensure robust products.

You will apply statistical analysis, validation, and risk management to test methods and processes, while mentoring engineers and leading cross-functional teams in a highly regulated environment.

Qualifications

• Minimum 6 years in Quality Engineering, Manufacturing Quality, Process Engineering, or similar.
• Experience with Test Method Validation (TMV) and with IQ/OQ/PQ.
• Experience in highly regulated industries.

Responsibilities

• Provide Quality Engineering leadership across Advanced Catheters and Extrusions programs from development to commercialization.
• Lead development and validation of products, processes, equipment, and test methods, including TMV and IQ/OQ/PQ.
• Apply data-driven analysis to capability studies, data analyses, and performance assessments.
• Support extrusion, polymer, catheter, and balloon technologies including material properties and tolerances.
• Collaborate across R&D, Process Engineering, Manufacturing, Operations and supplier quality to ensure robust products.

Skills

Quality engineering

Cross-functional collaboration

Data analysis

Statistical methods

Education

Bachelor's degree in engineering or scientific related fields

Master's degree in engineering or scientific related fields

Job description

Edwards Lifesciences is seeking a Principal Quality Engineer to support Advanced Catheters and Extrusions from early development to commercialization. You will partner with R&D, Process Engineering, Manufacturing, and Operations to drive quality decisions across multiple sites and ensure robust products.

You will apply statistical analysis, validation, and risk management to test methods and processes, while mentoring engineers and leading cross-functional teams in a highly regulated environment.