Senior NPI Engineer, Medical Devices (THV)

Edwards Lifesciences; Irvine (CA); On-site; USD 108,000 - 153,000; Full time

Job summary

Edwards Lifesciences is seeking a Senior Engineer, New Product Introduction in Irvine, CA to lead the commercialization of Class III implantable THV products. You will drive supply chain readiness, partner with R&D, Quality, and Operations, and ensure scalable manufacturing processes from early development through product launch.

The role requires a minimum of 4 years in NPI/NPD and manufacturing operations, plus the ability to travel up to 20%.

Qualifications

• Bachelor’s degree in Mechanical, Manufacturing, Industrial Engineering, or a related technical field.
• Minimum 4 years of experience in NPI/NPD and manufacturing operations.
• Ability to travel up to 20% (domestic and international).
• Onsite position in Irvine, CA.

Responsibilities

• Lead the commercialization of Class III implantable THV products, driving supply chain and manufacturing readiness from development through launch.
• Partners with R&D, Quality, Supplier Development, and Operations to ensure scalable manufacturing processes.
• Coordinate integration meetings to inform GO&Q and related functions on progress and risks.
• Develop supply chain strategies to achieve operational efficiency and support development needs.
• Ensure robust characterization and validation activities with R&D and quality, deploying critical control points in manufacturing.
• Identify manufacturing and supply risks and implement mitigation plans, aligning across sites.
• Drive continuous improvements in manufacturing processes with digital and Lean initiatives to elevate quality.
• Ensure accuracy of part drawings, BOMs, and manufacturing documentation; execute playbooks for sourcing, planning, transfer and supplier assessment.
• Incorporate DFM, Six Sigma, and LEAN considerations into product/process designs; support MES deployment as needed.
• Provide analysis and track progress against targets to meet commercialization metrics.

Skills

NPI/NPD experience

Manufacturing operations

Design transfers

Process validation

Travel up to 20%

Education

Bachelor’s degree in Mechanical/ Manufacturing/ Industrial Engineering

Job description

Edwards Lifesciences is seeking a Senior Engineer, New Product Introduction in Irvine, CA to lead the commercialization of Class III implantable THV products. You will drive supply chain readiness, partner with R&D, Quality, and Operations, and ensure scalable manufacturing processes from early development through product launch.

The role requires a minimum of 4 years in NPI/NPD and manufacturing operations, plus the ability to travel up to 20%.