Senior Manufacturing Engineer, NPD, AI&T

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.

How you will make an impact:

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

What you’ll need (Required):

Bachelor's Degree in Engineering or Scientific field with 4 years experience including either industry or industry/education OrMaster'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

What else we look for (Preferred):

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…