Senior Engineer, Supplier Quality
Edwards LifesciencesIrvine, California, United States
Posted March 12, 2026
108000 - 153000 USD
About the Company
Edwards Lifesciences (NYSE: EW), 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. 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. Contact Us We want to hear from you and engage in meaningful discussions. However, please note that we are not equipped to provide customer, candidate, or technical support through this platform. If you require assistance from those teams, please find their contact information here: https://www.edwards.com/aboutus/contactus If you’re a patient in need of medical advice, please contact your healthcare provider directly. We reserve the right to remove any comments that are off-topic, repetitive, or include hate speech, profanity, or offensive language. Additionally, we will not engage in discussions about competitor products, off-label use of Edwards products, or unsubstantiated/misleading claims that could cause harm. All Terms and Conditions of LinkedIn apply. For the Edwards Lifesciences privacy policy, visit https://www.edwards.com/legal/privacypolicy.
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.
Requirements
- Bachelor’s degree in Engineering or Scientific field with at least four (4) years of experience with either supplier quality, quality engineering, manufacturing, new product development/improvement, or production engineering activities
- Highly regulated industry experience
- Ability to travel up to 25%
- Engineering degree
- Medical Device, Aerospace, or Automotive industry experience
- Knowledge and understanding of FDA’s 21 CFR Part 820, ISO13485, ISO9001, and other International Regulatory Standards
- Experience and/or proficient knowledge of Design Controls and test method development/validations
- Demonstrated experience driving component testing, test method validations, and testing/validating equipment
- 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.)
- Good interpersonal skills, with the ability to negotiate and influence change
- Possess the ability to multi-task, while maintaining high attention to detail
- Ability to achieve results in cross-functional team environment and build strong relationships with internal and external customers(suppliers)
Benefits
- Competitive salaries
- Performance-based incentives
- Wide variety of benefits programs to address the diverse individual needs of our employees and their families