NPD Quality Engineer II - Life-Saving Medical Devices

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 87,000 - 123,000; Full time

Benefits offered by this job

Competitive salaries

Performance-based incentives

Benefits program

Job summary

Edwards Lifesciences Irvine is seeking a Quality Engineer in New Product Development to drive innovation while upholding regulatory and Edwards quality systems. You will develop experiments, validate processes, and maintain risk management files to enable safe, effective therapies for patients worldwide.

Join a collaborative team focused on design for manufacturing, CAPA investigations, and process improvement using Six Sigma/LEAN.

Qualifications

• Bachelor's degree in Engineering or a scientific field; 2 years of related experience.
• Master's degree or equivalent with internship, senior projects or thesis in Engineering or Science.
• CQE certification preferred.

Responsibilities

• Develop moderately complex experiments and tests; write protocols and analyze results.
• Maintain risk management files and investigate CAPA/non-conformances.
• Optimize manufacturing processes using Six Sigma and LEAN methods.
• Develop training materials and work instructions for production.
• Coordinate technicians and support task execution; mentor staff.

Skills

Quality engineering

Statistical analysis

Documentation

Communication

Problem solving

Lean Six Sigma

CAPA investigations

Team collaboration

Vendor management

Education

Bachelor's degree in Engineering or Science

Master's degree or equivalent

Job description

Edwards Lifesciences Irvine is seeking a Quality Engineer in New Product Development to drive innovation while upholding regulatory and Edwards quality systems. You will develop experiments, validate processes, and maintain risk management files to enable safe, effective therapies for patients worldwide.

Join a collaborative team focused on design for manufacturing, CAPA investigations, and process improvement using Six Sigma/LEAN.