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.
This Principal Quality Engineer, NPD will be part of Edwards Lifesciences growing Transcatheter Heart Valve (THV) business in Irvine, CA. We are looking for a strong engineer with solid technical expertise, who enjoys working in a fast paced and rapidly growing environment where taking initiative and collaborating cross-functionally are critical for success. The engineer will have a variety of responsibilities in New Product Development providing Quality Engineering support and leadership to ensure the successful design and development of new products.
How you will make an impact:
· Providing technical leadership for successful new product development projects by applying design control and risk management principles to positively influence new product development efforts from concept through product launch including design verification, validation, and design and manufacturing specification development.
· Partner and collaborate with cross-functional stakeholders and peers on new product development teams to align on goals and drive actions to meet commitments.
· Lead development and drive updates to risk management files for new products
· Lead test method development and validation activities for new designs
· Lead failure investigations for product failures in design testing and clinical use
· Lead development and implementation of inspection and testing mechanism for components, sub-assemblies, and final assemblies used in new product design and manufacturing
· Develop technical solutions to complex problems, recommend and implement corrective actions, using creativity, statistical techniques, and reliability engineering
· Collaborate with manufacturing and operations team to ensure successful transfer and launch of robust products.
· Managing/overseeing the work of an assigned team of direct reports within own function.
· Developing a robust talent development plan in alignment with functional growth strategies of the individual and the department.
· Ensure compliance with all Federal, State, local and company regulations, policies and procedures.
· Performs other incidental duties as assigned by management
· Ability to travel up to 10% domestically and internationally
What you’ll need (Required):
· Bachelor’s Degree in Engineering or Scientific field with a minimum of six (6) years related experience required; OR a Master’s Degree in Engineering or Scientific field with a minimum of five (5) years related experience; OR a PhD in Engineering or Scientific field with a minimum of two (2) year related experience.
· Knowledge of and experience with design control, risk management/usability engineering within medical device industry or other regulated industries
· Working knowledge of the Domestic and International regulatory requirements of Medical Device regulations (FDA 21 CFR 820, ISO 13485, ISO 14971, ISO 62366; and other applicable regulatory requirements)
What else we look for (Preferred):
· Current or prior experience within Medical Device industry
· Must be able to work in a team environment, including inter-departmental teams and key stakeholders representing the organization on projects
· Quality Engineering experience in New Product Development
· Knowledge and experience within Design Assurance, including Design Controls, Design Verification & Validation, Test Method Development, and Process Validation
· New Product Development experience from initial concept to commercialization (Class III preferred).
· ASQ Certified Quality Engineer (CQE), Quality System Lead Auditor, Certified Six Sigma Black Belt (CSSBB), or related quality/regulatory certifications a plus
· Strong documentation, communication, and interpersonal relationship skills including negotiating and relationship management skills
· Ability to prioritize, plan, and evaluate deliverables to established strategic goals
· Ability to interact professionally with all organizational levels
· Ability to manage competing priorities in a fast-paced environment
· Experience with Risk Management and Design Control
· Working knowledge of the Domestic and International regulatory requirements of Medical Device regulations
· Proven expertise in usage of MS Office Suite including MS Project
· Basic understanding of statistical techniques
· Strong problem-solving, organizational, analytical and critical thinking skills
· Experience in people leadership including direct line reporting responsibilities
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 and at least 6 years of related experience
- Alternatively, a Master's degree in Engineering or a Scientific field and at least 5 years of related experience
- Alternatively, a PhD in Engineering or a Scientific field and at least 2 years of related experience
- Knowledge and experience with design control, risk management, and usability engineering in the medical device industry or another regulated industry
- Working knowledge of domestic and international medical device regulations, including FDA 21 CFR 820, ISO 13485, ISO 14971, and ISO 62366
- Experience working in team environments, including interdepartmental teams and project stakeholders
- Quality Engineering experience in new product development
- Experience with Design Assurance, design controls, design verification and validation, test method development, and process validation
- New product development experience from initial concept through commercialization; Class III experience preferred
- ASQ Certified Quality Engineer, Quality System Lead Auditor, Certified Six Sigma Black Belt, or related quality or regulatory certification
- Strong documentation, communication, interpersonal, negotiation, and relationship management skills
- Ability to prioritize, plan, and evaluate deliverables against strategic goals
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast-paced environment
- Experience with risk management and design control
- Proven expertise using Microsoft Office Suite and Microsoft Project
- Basic understanding of statistical techniques
- Strong problem-solving, organizational, analytical, and critical-thinking skills
- Experience in people leadership, including direct line reporting responsibilities
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
