Principal 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

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

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

You will apply 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 product and manufacturing processes.

You will make an impact by:

• Serve as a Quality Engineering technical subject matter expert for AdvancedCatheters and Extrusions programs, providing technical guidance throughout new product development, new product introduction, pilot manufacturing, and commercialization.
• Lead Quality Engineering activities supporting the development and validation of products, manufacturing processes, equipment, and test methods, including Test Method Validation (TMV) and IQ/OQ/PQ activities.
• Apply a data-driven and statistical approach to Quality Engineering decisions, including capability studies, data analysis, experimental results, and assessment of process and product performance.
• Provide Quality Engineering expertise for extrusion, polymer, catheter, and balloon-related technologies, including evaluation of material properties, design requirements, tolerances, specifications, and associated product and manufacturing risks.
• Partner cross-functionally with R&D, Process Engineering, Manufacturing, Operations, Supplier Quality, and other Quality teams to develop robust products and manufacturing processes and support successful program execution.
• Collaborate across sites and with technical centers of excellence to support manufacturing readiness, validation, technology transfer, and commercialization activities.
• 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, helping build Quality Engineering capability and consistency across programs.

What you’ll need (Required)

• 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.

What else we look for (Preferred)

• Medical device industry experience supporting ClassII and/or ClassIII products.
• Experience with extrusion and/or polymer manufacturing processes, including material property testing and analysis.
• Experience supporting catheters, 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 an understanding of specifications and tolerancing.
• Experience leading cross-functional technical teams or projects and partnering effectively 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.

For California (CA), the base pay range for this position is $121,000 to $171,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

EdwardsLifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.