Senior Manufacturing Engineer, Heart Valve Ops

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

Benefits offered by this job

Competitive salary

Incentives program

Full benefits package

Job summary

Edwards Lifesciences is seeking a Senior Engineering Lead – Heart Valve Manufacturing in Irvine, CA. The role focuses on owning valve assembly processes, driving yield improvements, and supporting validations and scale-up across Surgical, THV, and TMTT lines.

You will collaborate with Operations, Quality, Regulatory, Supply Chain, and R&D to ensure product quality, regulatory compliance, and successful product launches.

Qualifications

• Bachelor’s degree in engineering or scientific field.
• On-site presence required for cross-functional collaboration.
• Lean or Black Belt certification preferred.
• ClassIII medical device manufacturing experience is a plus.

Responsibilities

• Provide technical ownership of valve assembly manufacturing processes and equipment.
• Lead complex process improvement initiatives to improve yield and throughput.
• Drive investigations, NCRs, CAPAs, and root cause analyses.
• Develop, execute, and document IQ/OQ/PQ validations and qualifications.
• Support design transfer and scale-up of new valve products and technologies.
• Collaborate with Operations, Quality, Regulatory, Supply Chain, and R&D to resolve issues.

Skills

Manufacturing engineering

Process validation

MS Office

Education

Bachelor’s degree in engineering or science

Tools

MS Office Suite

Job description

Edwards Lifesciences is seeking a Senior Engineering Lead – Heart Valve Manufacturing in Irvine, CA. The role focuses on owning valve assembly processes, driving yield improvements, and supporting validations and scale-up across Surgical, THV, and TMTT lines.

You will collaborate with Operations, Quality, Regulatory, Supply Chain, and R&D to ensure product quality, regulatory compliance, and successful product launches.