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. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
Do you thrive on solving difficult problems and turning innovative ideas into life-changing therapies? Our New Product Development Quality team works at the intersection of innovation, risk management, and patient impact. Partnering with engineers, clinicians, and cross-functional teams, you'll help shape the development of breakthrough medical technologies by solving complex challenges, reducing risk, and influencing critical decisions throughout the product development process.
In this role, you'll apply quality engineering expertise to enable innovation while ensuring compliance with regulatory requirements and Edwards' quality systems. Every project presents new opportunities to tackle technical challenges, collaborate with diverse teams, and help bring safe, effective, and reliable therapies to patients around the world.
How you will make an impact:
• Provide leadership and oversight for a device, system, or project to develop, update, and maintain design control documentation through product development processes. Support development of design requirement documentation.
• Develop, update, and maintain technical content of risk management and usability files
• Lead identification, development, and optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., Six Sigma and Lean manufacturing tools) for design for manufacturing and continuous process improvement initiatives. Identify opportunities and implement solutions for re-design/design of complex equipment, new technologies (including automation and software), tools, fixtures, etc. to improve manufacturing processes and/or test methods, and reduce overall process/product risk profile.
• Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and establish robust processes and/or test methods based on engineering principles; ensure completion of comprehensive usability studies, design verification and validation, validations for process and test methods, including analyzing results and developing reports; collaborate with cross-functional team members to facilitate project success and on-time completion
• Lead in the investigation of complex product quality and compliance issues (e.g., pre-commercial complaints, CAPA, non-conformances, audit observations, PRAs) during new product development and based on engineering principles; analyze results, make recommendations and develop reports. Act as subject matter expert for internal and/or external audits for products and/or processes. Support regulatory submissions and addressing responses during regulatory reviews.
• Train, coach, and guide lower-level employees on more complex procedures. Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work.
• Other incidental duties
What you'll need (Required Qualifications):
• Bachelor's Degree in in Engineering or Scientific field , 6 years’ experience, including either industry or industry/education or
• Master's Degree or equivalent in Engineering or Scientific field , 5 years’ experience, including either industry or industry/education or
• Ph.D. or equivalent in Engineering or Scientific field , 2 years’ experience, including either industry or industry/education
What else we look for (Preferred Qualifications):
• American Society for Quality Certification (ASQ) ASQ Certified Quality Engineer (CQE)
• Proven expertise in usage of MS Office Suite; CAD experience preferred
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
• Ability to translate technical information to all levels of the organizations
• Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering
• Advanced problem-solving, organizational, analytical and critical thinking skills
• Extensive understanding of processes and equipment used in assigned work
• Strong leadership skills and ability to influence change
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including frequent inter-organizational and outside customer contacts
• Represents organization in providing solutions to difficult technical issues associated with specific projects
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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 6 years of industry or industry/education experience
- Master’s degree or equivalent in Engineering or a scientific field and 5 years of industry or industry/education experience
- Ph.D. or equivalent in Engineering or a scientific field and 2 years of industry or industry/education experience
- ASQ Certified Quality Engineer (CQE) certification
- Expertise using Microsoft Office Suite
- CAD experience
- Excellent documentation, communication, interpersonal, negotiation, and relationship management skills
- Ability to translate technical information for all organizational levels
- Extensive knowledge of engineering principles, theories, and concepts
- Advanced problem-solving, organizational, analytical, and critical-thinking skills
- Extensive understanding of processes and equipment used in assigned work
- Strong leadership skills and ability to influence change
- Knowledge of Environmental Health and Safety and Quality guidelines for cleanroom medical device manufacturing
- Strict attention to detail
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast-paced environment
- Ability to work in a team environment with frequent inter-organizational and outside customer contacts
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
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