New · posted Oct 28
Edwards Lifesciences · Medical Devices
Principal Quality Engineer, Advanced Catheters & Extrusions
- Irvine, CA
- On-site
- Full-time
- Senior & Principal
The role
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.
What you need
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)nice to have
- 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.
Skills named in this posting
What you'll do
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
Pay and benefits
$121,000 – $171,000 a year
Employer providedCompetitive salaries
Performance-based incentives
Wide variety of benefits programs for employees and families
Where you'll work
Irvine, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Irvine, CAEqual opportunity, accessibility and legal noticesEdwards Lifesciences's statements, word for word
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Job intelligence
The context around this role
Live data · October 28, 2026
Salary intelligence
How the pay compares
This role's midpoint is 21% above the US median for Validation & CQV roles at this level.
This roleEmployer provided
Senior & Principal roles in California9 roles publishing pay
Senior & Principal roles in the US56 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $121,000 | — | $171,000 |
| California (middle half) | $123,000 | $127,000 | $137,500 |
| All US (middle half) | $105,375 | $121,000 | $132,250 |
This role: Edwards Lifesciences's own published range. Comparisons: the base pay employers published on open Validation & CQV roles at the same level on Regulatory Jobs, October 28, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Validation & CQV
The general path across 123 open Validation & CQV roles on Regulatory Jobs, with the titles they carry most. Not Edwards Lifesciences's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 27 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership8
- Lab testing and methods7
- Validation and qualification7
- Quality systems and risk3
- GMP and compliance1
- Documentation and SOPs1
- Investigations and CAPA1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Edwards Lifesciences on Regulatory Jobs
- 28
- Open roles
- 28
- Distinct roles
- 4
- Locations
By discipline
- Quality19 68%
- Regulatory8 29%
- Compliance & Safety1 4%
By level
- Senior & Principal16 57%
- Associate & Specialist8 29%
- Director2 7%
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Principal Quality Engineer, Advanced Catheters & Extrusions at Edwards Lifesciences
Open until filled. $121K–$171K a year, employer provided.