Manufacturing Process Engineer – Heart Valve Systems

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

Benefits offered by this job

Competitive salaries

Performance-based incentives

Benefits programs

Job summary

Edwards Lifesciences Irvine is seeking an Engineer to lead optimization, validation, and lifecycle support of heart valve manufacturing processes across multiple product lines. You will own valve assembly manufacturing processes, equipment, and product quality, and drive process improvements to enhance yield, quality, ergonomics, throughput, and labor efficiency.

The role requires a Bachelor's in engineering or science, manufacturing experience in a regulated environment, and on-site

Qualifications

• Bachelor's degree in engineering or scientific.
• Manufacturing experience in a highly regulated environment.
• On-site presence required to effectively collaborate cross-functionally, and support manufacturing operations.

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 engineering

Process validation

DFM

FDA guidelines

EH&S guidelines

Communication skills

Problem solving

Education

Bachelor's degree in engineering or scientific

Master's degree in Mechanical or Biomedical or MBA

Tools

MS Office Suite

Job description

Edwards Lifesciences Irvine is seeking an Engineer to lead optimization, validation, and lifecycle support of heart valve manufacturing processes across multiple product lines. You will own valve assembly manufacturing processes, equipment, and product quality, and drive process improvements to enhance yield, quality, ergonomics, throughput, and labor efficiency.

The role requires a Bachelor's in engineering or science, manufacturing experience in a regulated environment, and on-site