Senior Manufacturing Engineer, Pilot at Edwards Lifesciences in Irvine, CA

Job description

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Senior Manufacturing Engineer position is a unique career opportunity that could be your next step towards an exciting future. 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 NPD Engineer, manufacturing operations and other related functions, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world. How you’ll make an impact: 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. What you’ll need (Required): Bachelor’s degree in Engineering or a related scientific field