Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
The THV Balloon Expandable Delivery System New Product Development (NPD) team is looking for a Principal Engineer to support the development of our next-generation balloon expandable delivery systems. The Principal Engineer will have the opportunity to drive process design and characterization, work on a strong cross-functional team, and partner with the commercial site on process validations and commercialization activities.
How you will make an impact:
Develop manufacturing processes suitable for Class II/III medical devices; apply design controls, traceability, and change management throughout product development and commercialization.
Design and execute experiments, analyze data, establish process windows, and continuously improve manufacturing capability using statistical and engineering methodologies.
Lead validation strategies and execution for equipment, software, processes, and manufacturing systems.
Develop scaling and replication approaches for equipment and processes across sites, including comparability studies to demonstrate equivalency between pilot and production environments.
Develop approaches for scaling and replicating manufacturing equipment and processes across sites.
Design and support manufacturing automation and digital infrastructure, including PLCs, SCADA, MES, industrial networking, and electronic records.
Lead highly matrixed teams across organizations, functions, suppliers, and manufacturing locations.
Serve as a trusted advisor across R&D, Manufacturing, Quality, Project Management, and suppliers; communicate risks, tradeoffs, and recommendations to build alignment and resolve complex challenges.
What you'll need:
Bachelor's Degree in Engineering or Scientific field with 6 years of related experience, including either industry or industry/education, OR
Master's Degree in Engineering or Scientific field with 5 years of related experience, including either industry or industry/education.
What else we look for:
Relevant experience and expertise working in the medical device industry, specifically within manufacturing operations and/or New Product Development.
Demonstrated knowledge of catheter assembly process technologies, including adhesive bonding, thermal bonding, tube flaring, coatings, vision systems, plastics, metals, and related manufacturing technologies.
Strong understanding of mechanical systems, sensors, actuators, pneumatics, motors, drives, controls, troubleshooting, and machine safety principles.
Hands-on, execution-focused, comfortable operating in ambiguity, motivated by patient impact, and skilled at bridging innovation with manufacturing reality.
Technical experience in a manufacturing engineering environment, including sound understanding of current Good Manufacturing Practices (cGMP) and Environmental Health & Safety (EH&S).
Process development and excellence: Design for Manufacturability (DFM), Six Sigma, and LEAN.
Prior experience working with supplier development teams.
Excellent written and verbal communication and interpersonal skills, including negotiation and relationship management, with the ability to drive achievement of objectives.
Expert understanding of critical-to-quality (CTQ) design elements, cascading CTQs to design inputs/outputs, and establishing process controls/limits.
Experience with the development-through-commercialization process of medical devices.
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.
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 6 years of related experience, including industry or industry/education experience
- Master's degree in Engineering or a Scientific field with 5 years of related experience, including industry or industry/education experience
- Experience in the medical device industry, specifically manufacturing operations and/or new product development
- Experience with catheter assembly technologies, including adhesive bonding, thermal bonding, tube flaring, coatings, vision systems, plastics, metals, and related manufacturing technologies
- Knowledge of mechanical systems, sensors, actuators, pneumatics, motors, drives, controls, troubleshooting, and machine safety
- Technical experience in a manufacturing engineering environment, including cGMP and EH&S knowledge
- Experience with design for manufacturability, Six Sigma, and LEAN
- Experience working with supplier development teams
- Expert understanding of critical-to-quality design elements, cascading CTQs to design inputs and outputs, and establishing process controls and limits
- Experience with medical device development through commercialization
- Excellent written and verbal communication, interpersonal, negotiation, and relationship management skills
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
