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 technical engineering, strategic business planning, process innovation, product compliance, supplier management, or enabling supply chain operations, you will be making a meaningful contribution to our team and to patients all over the world.
Innovation starts from the heart. Heart valve disease impact millions of lives, spanning all ages and geographies. As communities globally address the opportunities and challenges of cardiovascular care, telling a compelling and authentic story is more crucial than ever. At Edwards Lifesciences, our Manufacturing and Engineering teams develop tools, technologies, and processes to power the production of life-changing medical devices to transform patients’ lives.
Within the Tissue Process Engineering Group (TPEG), the Senior Engineer will support the development, characterization, validation, and deployment of next-generation tissue manufacturing technologies with a strong emphasis on laser-based manufacturing systems.
How you’ll make an impact:
Serve as a key technical contributor for programs involving laser processing, automation, vision systems, equipment development, and process scale-up, helping transition innovative technologies from early feasibility through manufacturing implementation and global deployment.
Collaborate with equipment suppliers and internal stakeholders to define requirements, evaluate system performance, troubleshoot technical issues, and implement improvements.
Support equipment commissioning, factory acceptance testing (FAT), site acceptance testing (SAT), and qualification activities.
Design and execute experiments to characterize process and/or equipment and evaluate technology capability, including material interactions, system performance, and manufacturing robustness.
Develop and execute characterization, verification, validation, and process qualification protocols and reports in accordance with regulatory and quality requirements.
Participate in risk management activities including hazard analysis, FMEA development, and mitigation planning.
Support technology transfer activities between development, pilot, and global manufacturing sites.
Investigate manufacturing, equipment, and process issues, supporting CAPA and continuous improvement initiatives.
What you’ll need:
Bachelor’s degree in engineering or scientific with 4 years of engineering experience including technology site transfers in a highly regulated environment.
Travel up to 25% domestically and internationally.
Onsite required.
What else we look for:
Advanced degree and/or Lean Six Sigma certification.
Experience with laser processing technologies, including ultrashort pulse, fiber, CO₂, femtosecond, picosecond, or similar laser systems.
Experience working with suppliers and external development partners to support the design, development, and implementation of custom manufacturing equipment. Experience supporting the transfer of manufacturing equipment, processes, or technologies across sites, production lines, or product platforms.
Knowledge of equipment development and deployment activities, including supplier selection, design reviews, factory acceptance testing (FAT), site acceptance testing (SAT), commissioning, validation, and production readiness.
Hands-on experience in manufacturing process development, characterization, optimization, and troubleshooting of complex equipment or laser-based manufacturing processes.
Experience developing and executing characterization studies, IQ/OQ/PQ protocols, and other equipment qualification and validation activities.
Ability to author and maintain technical documentation, validation reports, and engineering records in compliance with quality system and regulatory requirements.
Strong cross-functional collaboration skills with the ability to work effectively with Manufacturing, Quality, R&D, Supply Chain, and external partners in a regulated environment.
For California, the base pay range for this position is $108,000 - $153,000 (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
- Minimum 4 years of engineering experience in a highly regulated environment
- Experience with technology site transfers in a regulated manufacturing environment
- Onsite work required
- Willingness to travel up to 25% domestically and internationally
- Advanced degree and/or Lean Six Sigma certification
- Experience with laser processing technologies (ultrashort pulse, fiber, CO2, femtosecond, picosecond)
- Experience working with suppliers and external development partners for custom manufacturing equipment
- Experience with equipment development and deployment activities including FAT, SAT, commissioning, validation, and production readiness
- Hands-on experience in manufacturing process development, characterization, optimization, and troubleshooting of complex equipment or laser-based processes
- Experience developing and executing IQ/OQ/PQ protocols and equipment qualification/validation activities
- Ability to author and maintain technical documentation, validation reports, and engineering records compliant with quality system and regulatory requirements
- Strong cross-functional collaboration skills with Manufacturing, Quality, R&D, and Supply Chain
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.
-
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.
-
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.
-
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
