Manufacturing Engineer I - Heart Valve Devices

Edwards Lifesciences; Irvine (CA); On-site; USD 69,000 - 98,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Manufacturing Engineer to own valve assembly processes across Surgical, THV, and TMTT lines. You will lead validation, equipment qualification, and continuous improvement, partnering with Operations, Quality, Regulatory, Supply Chain, and R&D.

Requirements: Bachelor’s degree in engineering or science; manufacturing experience in a highly regulated environment; on-site presence.

Qualifications

• Bachelor’s degree in engineering or scientific field required.
• Manufacturing experience in a highly regulated environment.
• On-site presence required to effectively collaborate cross-functionally.

Responsibilities

• Provide technical ownership of valve assembly manufacturing processes, equipment, and product quality.
• Support complex process improvement initiatives to improve yield, quality, ergonomics, throughput, and labor efficiency.
• Participate in manufacturing investigations, NCRs, CAPAs, and root cause analyses using structured problem-solving methods.
• Develop, execute, and document process validations and equipment qualifications (IQ/OQ/PQ).
• Support commercialization, design transfer, and scale-up of new valve products and manufacturing technologies.
• Assess manufacturing risks and implement sustainable corrective and preventive actions.
• Partner with cross-functional teams to resolve complex technical issues, drive project execution, and develop scalable manufacturing processes.

Skills

Manufacturing experience

Cross-functional collaboration

On-site collaboration

MS Office Suite

DFM

EH&S guidelines

FDA guidelines

Process validation

Education

Bachelor’s degree in engineering or science

Tools

MS Office Suite

Job description

Edwards Lifesciences in Irvine, CA is seeking a Manufacturing Engineer to own valve assembly processes across Surgical, THV, and TMTT lines. You will lead validation, equipment qualification, and continuous improvement, partnering with Operations, Quality, Regulatory, Supply Chain, and R&D.

Requirements: Bachelor’s degree in engineering or science; manufacturing experience in a highly regulated environment; on-site presence.