Senior Manufacturing Engineer - Medical Devices & Process Improvement

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

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Senior Engineer to shape manufacturing for THV/TMTT portfolios. You will lead qualification, installation, and validation of a new sterilization tank while coordinating with global teams to ensure compliant, efficient processes.

Role requires lean/six-sigma expertise and strong project management to drive equipment implementation, process validation, and continuous improvement across manufacturing operations.

Qualifications

• Bachelor's degree in Engineering or a scientific field with 4 years in manufacturing engineering.
• Onsite presence is required to support manufacturing operations.
• Experience in a highly regulated medical device environment is preferred.

Responsibilities

• Improve manufacturing processes using engineering methods for continuous improvement.
• Develop experiments and tests to qualify and validate processes; analyze results.
• Analyze and resolve CAPA, non-conformances, and audit observations.
• Develop work instructions and training materials for production.
• Lead cross-functional teams for equipment implementation and improvements.
• Create URS/CQ/IQ/OQ/PQ documentation to support validation activities.

Skills

LEAN methods

Six Sigma

Project management

Statistical analysis

CAPA

Process validation

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Science

Tools

MS Project

MS Office

MES

Job description

Edwards Lifesciences in Irvine, CA is seeking a Senior Engineer to shape manufacturing for THV/TMTT portfolios. You will lead qualification, installation, and validation of a new sterilization tank while coordinating with global teams to ensure compliant, efficient processes.

Role requires lean/six-sigma expertise and strong project management to drive equipment implementation, process validation, and continuous improvement across manufacturing operations.