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Irvine, California, United States
Onsite
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.