Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
The Principal Engineer will serve as a key technical subject matter expert, partnering closely with internal teams and external suppliers to ensure product designs meet user needs - including ease of use, manufacturability, cost effectiveness, and operational efficiency. In addition to deep technical leadership, this role requires strong project management capabilities and a thorough understanding of Design Control to drive effective, compliant, and timely project execution.
How you’ll make an impact:
- Supplier Validation and Product Development Process: Lead the end-to-end technical validation of suppliers during product development, from component design and GD&T reviews to process characterization, capability analysis, and strategic process validation, ensuring robust DFM/DFA integration and quality compliance across all development stages.
- Build and maintain strong partnerships with R&D, Program Management, Manufacturing, Supplier Quality, and key suppliers to ensure seamless project execution and compliance with internal procedures, QSR, FDA regulations, ISO 13485 standards, and risk management best practices.
- Support and contribute to product development efforts by influencing the design and iteration of next‑generation systems and components for IHFM.
- Lead cross‑functional teams and external suppliers in the design, development, and testing of complex interventional catheter delivery systems for implantable devices.
- Oversee and drive timelines for feasibility studies, design verification testing, clinical evaluations, and supplier validation activities required for commercial release.
- Perform other duties and responsibilities as assigned.
What you'll need (Required):
- Bachelor's degree in engineering or scientific, with 6 years of experience in new product development, process development, commercialization, and/or operations engineering in a highly regulated environment.
- Travel up to 25% domestically and internationally.
- On-site work required.
What else we look for (Preferred):
- Master’s degree in engineering and/or MBA.
- Certification or formal training in Lean Six Sigma.
- Strong background in sensor based medical device development, with hands-on experience in design optimization and advancing innovative technologies from concept through commercialization.
- Hands-on experience with electronic manufacturing processes.
- Experience working within ISO 1348 -compliant quality systems and applying risk management principles throughout product development and commercialization.
- Background in at least two of the following areas: interventional access devices, rapid product development, component-level manufacturing, or complex assembly design.
- Demonstrated capability to apply sound engineering judgment and technical expertise to solve complex problems; working knowledge of DFM, GD&T, and Six Sigma methodologies.
- Proven ability to manage and collaborate with external vendors to meet quality, timeline, and technical requirements.
- Strong experience in rapid product development within cross‑functional teams, including creative design iteration, prototyping, and test method development (e.g., in‑vitro testing).
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 scientific field
- 6 years experience in new product development, process development, commercialization, and/or operations engineering in a highly regulated environment
- Travel up to 25% domestically and internationally
- On-site work required
- Master's degree in engineering and/or MBA
- Certification or formal training in Lean Six Sigma
- Background in sensor-based medical device development and advancing technologies from concept through commercialization
- Hands-on experience with electronic manufacturing processes
- Experience working within ISO 13485-compliant quality systems and applying risk management principles
- Background in at least two of: interventional access devices, rapid product development, component-level manufacturing, or complex assembly design
- Working knowledge of DFM, GD&T, and Six Sigma methodologies
- Proven ability to manage and collaborate with external vendors to meet quality, timeline, and technical requirements
- Experience in rapid product development including prototyping and test method development (e.g., in-vitro testing)
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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Retirement Support — Retirement programs include a 401(k) match complemented by a separate profit‑sharing contribution. These elements add meaningful 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, alongside stock awards for eligible roles, provides notable upside. Program expansions indicate continued accessibility.
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Leave & Time Off Breadth — Time‑off policies include generous PTO, company holidays, and a year‑end holiday shutdown. These offerings enhance work‑life support when available at the site.
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
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