Principal Quality Engineer, Advanced Catheters & Extrusions

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

Job summary

Edwards is seeking a Principal Quality Engineer to act as a technical QA expert supporting Advanced Catheters and Extrusions from early development through commercialization. You will partner with R&D, Process Engineering, Manufacturing, Operations and other Quality teams across sites to provide leadership on validation, testing, and risk management.

The role requires a strong background in Test Method Validation, IQ/OQ/PQ, and experience in a highly regulated medical device environment.

Qualifications

• Bachelor's or Master's in engineering/science with related experience in quality
• Experience with Test Method Validation and process/equipment validation (IQ/OQ/PQ)
• Highly regulated industry experience required

Responsibilities

• Serve as QA SME for Advanced Catheters and Extrusions from development to commercialization.
• Lead QA activities supporting development, validation of products, processes, equipment and test methods.
• Apply data-driven approach to capability studies, data analysis and risk assessment for products and processes.
• Provide QA expertise for 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.
• Support manufacturing readiness, technology transfer, and commercialization across sites.
• Develop and approve validation protocols, reports, specifications and risk management documentation.
• Lead investigations, CAPAs, and supplier quality issues as needed.
• Mentor engineers and technicians to build QA capability across programs.

Skills

Quality Engineering

Process Engineering

Statistical analysis

CAPA

IQ/OQ/PQ

Education

Bachelor's degree in engineering or scientific related fields

Master's degree in engineering or scientific related fields

Tools

TMV

IQ/OQ/PQ

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 Advanced Catheters 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.
• Other incidental duties

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 Class II and/or Class III 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.

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
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). Applications will be accepted while this position is posted on our Careers website.