Senior Manufacturing Engineer, NPD, AI&T

Edwards Lifesciences • Irvine, CA

1d • $108,000 - $153,000

About The Position

Innovation starts from the heart. Our Advanced Innovation & Technology (AI&T) teams harness the imagination, courage, and resourcefulness to think beyond what’s currently possible, and create solutions for patients many years into the future. If you’re an early-stage innovator, then Edwards AI&T team is the place for you to take the next steps in your career. We’ll give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology. 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 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.

Requirements

• Bachelor's Degree in Engineering or Scientific field with 4 years experience including either industry or industry/education
• Or Master's Degree or equivalent in Engineering or Scientific field with 3 years experience including either industry or industry/education
• Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education

Nice To Haves

• Experience with Edwards systems and training, including Windchill (PLM), strongly preferred, with demonstrated ability to navigate and leverage these tools to support product development and documentation processes
• Working knowledge of CAD and engineering design tools (as applicable), along with proficiency in MS Office Suite (including MS Project) to support technical analysis, planning, and execution
• Strong understanding of engineering principles, manufacturing processes, and equipment relevant to assigned areas, with the ability to apply this knowledge to solve complex problems
• Knowledge of applicable FDA regulations within the medical device industry, ensuring alignment with compliance, quality, and audit expectations
• Experience working with lab and/or industrial equipment (as applicable) to support testing, validation, and manufacturing activities
• Foundational understanding of statistical techniques to support data-driven decision making and process validation
• Demonstrated problem-solving, analytical, and critical thinking skills, with the ability to diagnose issues and recommend effective solutions
• Strong documentation and communication skills (written and verbal), with the ability to clearly convey technical information and engage effectively across stakeholders
• Proven leadership and influencing skills, with the ability to drive change and collaborate across cross-functional teams
• Strong organizational skills and ability to manage competing priorities in a fast-paced NPD and manufacturing environment
• Demonstrated attention to detail to ensure accuracy, quality, and compliance in all outputs
• Ability to build effective working relationships and interact professionally across all levels of the organization, including serving as a key contact on cross-functional projects
• Ability to work effectively in team environments, including interdepartmental collaboration and project-based work

Responsibilities

• Drive optimization and redesign of manufacturing processes by applying advanced engineering methodologies (e.g., Six Sigma, Lean) to improve efficiency, quality, and scalability; ensure equipment, tooling, and fixtures meet performance and compliance standards
• Lead complex process development, qualification, and validation activities by designing and executing experiments and protocols; analyze data, generate insights, and deliver recommendations and technical reports
• Resolve complex manufacturing and compliance issues including CAPAs, non-conformances, and audit observations, ensuring timely root cause identification and sustainable corrective actions
• Own and execute project plans for NPD initiatives by defining deliverables, managing risks, and ensuring alignment to customer expectations using structured project management tools and methodologies
• Provide technical leadership on the production floor by overseeing manufacturing support activities, guiding and developing technicians, and ensuring effective execution of testing and process controls
• Enable knowledge transfer and process adoption by developing clear, standardized documentation (e.g., work instructions, training materials) to support production readiness and operational consistency
• Perform other incidental duties as assigned by leadership
• 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

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