Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.
Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.
The Senior Engineer will lead the optimization, validation, and lifecycle support of heart valve manufacturing processes across Surgical, Transcatheter Heart Valve (THV), and Transcatheter Mitral & Tricuspid Therapies (TMTT) product lines.
How you’ll make an impact:
Provide technical ownership of valve assembly manufacturing processes, equipment, and product quality.
Lead complex process improvement initiatives to improve yield, quality, ergonomics, throughput, and labor efficiency.
Drive manufacturing investigations, NCRs, CAPAs, and root cause analyses using structured problem-solving methods.
Develop, execute, and document process validations and equipment qualifications (IQ/OQ/PQ).
Support commercialization, design transfer, and scale-up of new valve products and manufacturing technologies.
Assess manufacturing risks and implement sustainable corrective and preventive actions.
Partner with cross-functional teams, including Operations, Quality, Regulatory, Supply Chain, and R&D, to resolve complex technical issues, drive project execution, and develop scalable manufacturing processes that support product quality, regulatory compliance, operational efficiency, and successful product launches.
What you’ll need:
Bachelor’s degree in engineering or scientific with 4 years of manufacturing experience in a highly regulated environment.
On‑site presence required to effectively collaborate cross‑functionally, and support manufacturing operations.
What else we look for:
Master’s degree; MBA, Mechanical, or Biomedical degree.
Lean or Black Belt certification.
Class III medical device manufacturing experience.
Strong technical skillset in manufacturing engineering: design for manufacturability (DFM), EH&S guidelines, FDA guidelines, and process validation.
Experience leading scale-up and manufacturing implementation projects.
Effective communication and interpersonal skills at all levels of employees, suppliers, and consultants.
Excellent documentation, communication, and interpersonal relationship skills including negotiating and relationship management.
Advanced problem-solving, organizational, analytical, and critical thinking skills.
Proven expertise in MS Office Suite.
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 $108,000 - $153,000 in tool (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 discipline
- Four years of manufacturing experience in a highly regulated environment
- On-site presence to collaborate cross-functionally and support manufacturing operations
- Master's degree, MBA, Mechanical Engineering, or Biomedical Engineering degree
- Lean or Black Belt certification
- Class III medical device manufacturing experience
- Manufacturing engineering expertise, including design for manufacturability, EH&S guidelines, FDA guidelines, and process validation
- Experience leading scale-up and manufacturing implementation projects
- Effective communication and interpersonal skills with employees, suppliers, and consultants
- Documentation, communication, negotiation, and relationship management skills
- Advanced problem-solving, organizational, analytical, and critical-thinking skills
- Expertise in Microsoft Office Suite
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
