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 Supplier Quality Engineer II will play a key role on critical projects within the Surgical business unit. This position is cross-functional in nature and requires strong collaboration and partnership with R&D, Design Assurance, Operations, Regulatory Affairs, Supplier Development Engineering and Receiving Inspection. The primary focus of the position is leading successful parts qualification efforts with external suppliers to support product development and commercial launch timelines. Will also be responsible for resolving manufacturing quality issues, supporting CAPA/non-conformances, validating and improving processes, managing risk documentation, and driving Lean/Six Sigma improvements while ensuring regulatory and quality-system compliance. This role will work on-site in a very fast-paced and dynamic environment where being proactive and taking initiative is paramount to success.
How you will make an impact:
- Facilitate/perform gage studies, process capability studies, and supplier process validations related to critical component features based on risks identified in FMEAs.
- Develop and validate test methods, which can encompass creating inspection routines on optical measurement equipment and design and creation of inspection fixtures using SolidWorks.
- Manage component and supplier qualification activities from initiation to closure.
- Supports completion of Design File requirements applicable to supplied components, subassemblies, devices, and services.
- Create test method procedures and provide training. Provide engineering support to Receiving Inspection on component test methods and investigations.
- Conduct on-site supplier audits.
- Manage supplier-related non-conformances.
- Manage supplier corrective action requests from initiation to closure.
- Report on supplier part qualification status at recurring cross-functional project meetings
What you’ll need (Required):
- Bachelor’s degree in engineering or scientific field with at least 2 years of experience with either supplier quality, quality, manufacturing, or production engineering activities; OR Master’s degree with no experience (or internship/co-op experience).
- Highly regulated industry experience.
- Must have ability to travel up to 15% - 20%.
- Must be willing and able to work onsite 100%.
What else we look for (Preferred):
- Engineering degree
- Medical Device, Aerospace, or Automotive industry experience.
- Experience and/or proficient knowledge of Design Controls and test method development/validations.
- Experience with statistical techniques and tools such as Gage R&R, Statistical Process Control, or Process Capability Studies.
- Ability to conduct effective root cause analysis; driving non-conformance investigations; and assessment of corrective action strategies and effectiveness as applied through CAPAs.
- Knowledge of GD&T and ability to read and interpret drawings.
- Good understanding of process validations (IQ, OQ, PQ)
- Good understanding of manufacturing processes (i.e., injection molding, extrusion, machining, etc.).
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, the base pay range for this position is $87,000 - $123,000 (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.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Skills Required
- Bachelor's degree in engineering or a scientific field with at least 2 years of supplier quality, quality, manufacturing, or production engineering experience
- Master's degree with no experience, or internship/co-op experience
- Experience in a highly regulated industry
- Ability to travel 15%–20%
- Willingness and ability to work onsite 100%
- Engineering degree
- Medical device, aerospace, or automotive industry experience
- Knowledge of Design Controls and test method development or validation
- Experience with Gage R&R, Statistical Process Control, or process capability studies
- Root cause analysis, non-conformance investigations, and CAPA corrective action assessment
- Knowledge of GD&T and ability to read and interpret drawings
- Knowledge of IQ, OQ, and PQ process validations
- Understanding of manufacturing processes such as injection molding, extrusion, and machining
Edwards Lifesciences Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Edwards Lifesciences and has not been reviewed or approved by Edwards Lifesciences.
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Healthcare Strength — Health coverage is considered strong, with multiple plan choices, HSA options, and fertility support, and the company highlights holistic well‑being programs.
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Retirement Support — A company 401(k) match and well‑regarded retirement offerings add clear long‑term value to total compensation.
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Equity Value & Accessibility — An Employee Stock Purchase Plan with a discount and look‑back feature makes equity ownership accessible and enhances the total rewards package.
Edwards Lifesciences Insights
What We Do
Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more. Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today. Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives. Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life. For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms
