Senior Manufacturing Engineer, Pilot

Edwards Lifesciences • Irvine, CA

2d • Onsite

About The Position

Edwards Lifesciences is a leading global structural heart innovation company dedicated to improving patient lives. This Senior Manufacturing Engineer position is within the Global Operations & Quality team, focusing on ensuring the delivery of products to patients with cardiovascular disease. The role involves cross-functional collaboration with NPD Engineer, manufacturing operations, and other related functions to solve complex challenges and develop knowledge of the medical device industry. Responsibilities span strategic inventory planning, labeling, warehouse management, and material handling, all contributing to patient well-being.

Requirements

• Bachelor’s degree in Engineering or a related scientific field and 4 years of relevant experience including either industry or industry/ education; or Master’s degree or equivalent in Engineering or a related scientific field and 3 years of experience including either industry or industry/ education
• Strong documentation, verbal communication, organizational, analytical, and critical-thinking skills.
• Ability to manage competing priorities and maintain sound decision-making in a fast-paced, high-visibility manufacturing environment.
• Substantial knowledge of engineering principles, manufacturing processes, equipment, process validation, and structured problem-solving techniques.
• Working knowledge of statistical techniques, Lean manufacturing, and Six Sigma methodologies.
• Experience developing and executing protocols, analyzing technical data, and documenting conclusions and recommendations.
• Knowledge of applicable medical device regulations, quality system requirements, and clean-room manufacturing practices.
• Proficiency with Microsoft Office, including Microsoft Project

Nice To Haves

• Demonstrated experience providing hands-on engineering support for manufacturing builds, engineering development builds, pilot production, NPD, or sustaining manufacturing activities.
• Strong technical leadership skills, with the confidence to make recommendations, drive decisions, and lead teams through complex or time-sensitive manufacturing challenges.
• Proven ability to troubleshoot manufacturing processes and equipment directly on the production floor, including situations where the issue is not immediately defined.
• Ability to lean into ambiguity, ask effective questions, investigate issues deeply, and identify practical solutions using technical analysis and sound engineering judgment.
• Strong interpersonal and relationship-management skills, with the ability to build credibility with production operators, technicians, engineers, and senior stakeholders.
• Confidence communicating complex technical topics and constructively giving and receiving pushback to support informed, risk-based decisions.
• Experience leading, training, or mentoring technicians and less-experienced engineers, particularly during manufacturing or development builds.
• Ability to influence cross-functional teams and establish strategic partnerships across Manufacturing, Quality, R&D, NPD, and Sustaining Engineering.
• Comfort working directly with operators and technicians, using a hands-on approach to understand equipment, processes, materials, and manufacturing challenges.
• Experience using or learning Manufacturing Execution Systems or other complex digital manufacturing systems.
• Willingness and ability to spend significant time in a clean-room manufacturing environment, including wearing required gowning and remaining on your feet while supporting builds.
• Flexibility to provide occasional early-morning support for critical manufacturing builds, including start times as early as 6:30 a.m.
• CAD experience preferred.

Responsibilities

• Provide visible, hands-on engineering leadership during manufacturing and engineering development builds, working directly on the production floor to anticipate risks, troubleshoot issues, and maintain build execution.
• Independently investigate complex manufacturing challenges by asking thoughtful questions, examining processes in detail, analyzing data, and driving issues through resolution.
• Lead technical troubleshooting efforts when problems arise during critical builds, bringing structure, urgency, and sound engineering judgment to ambiguous situations.
• Partner closely with operators, technicians, Manufacturing, Quality, R&D, NPD, and Sustaining Engineering teams to identify risks, resolve issues, and strengthen manufacturing readiness.
• Build strong relationships with production operators and technicians, actively seeking their input and translating observations from the manufacturing floor into effective engineering solutions.
• Confidently communicate complex technical information, recommendations, risks, and tradeoffs to stakeholders across organizational levels.
• Provide clear technical direction while remaining open to challenge, constructively giving and receiving pushback when needed to reach the best solution.
• Apply technical principles, engineering methods, and Edwards systems and procedures to optimize manufacturing processes, equipment, tools, and fixtures.
• Identify and lead opportunities to improve manufacturing performance using Lean, Six Sigma, and other structured problem-solving methodologies.
• Develop and execute complex experiments, tests, and protocols to qualify and validate manufacturing processes; analyze results, assess risk, make recommendations, and prepare clear technical reports.
• Lead the investigation and resolution of complex manufacturing and compliance issues, including CAPAs, nonconformances, and audit observations.
• Develop project plans, risk assessments, and execution strategies that align cross-functional teams and ensure critical deliverables are completed successfully.
• Develop training materials, work instructions, and technical documentation that enable effective knowledge transfer and consistent manufacturing execution.
• Guide, train, and mentor technicians and less-experienced engineers, providing clear direction, timely feedback, and support during manufacturing activities.
• Develop working expertise in complex digital manufacturing systems, including Manufacturing Execution Systems, and use those systems to support build execution and process improvement.
• Adapt quickly to changing project needs and technical challenges while supporting new, complex, and highly visible product programs in a fast-paced pilot manufacturing environment.

Benefits

• competitive salaries
• performance-based incentives
• a wide variety of benefits programs to address the diverse individual needs of our employees and their families

What This Job Offers

• Job Type: Full-time
• Career Level: Senior