Senior Quality Engineer – Medical Devices

Edwards Lifesciences; Irvine, Northern (CA, KY); Hybrid; USD 121,000 - 171,000; Full time

Job summary

Edwards Lifesciences in California is seeking a Quality Engineer to lead device design controls, risk management, and manufacturing process optimization within our New Product Development Quality team. You’ll collaborate with engineers, clinicians, and cross-functional teams to ensure compliant, high-quality medical devices that improve patient outcomes.

The role emphasizes leadership, problem solving, and adherence to Edwards’ quality systems, with opportunities to influence product lifecycle

Qualifications

• Bachelor's degree in Engineering or Scientific field required; 6+ years experience
• Master's degree or equivalent with 5+ years experience preferred
• Ph.D. or equivalent with 2+ years experience preferred

Responsibilities

• Provide leadership and oversight for a device, system, or project to develop, update, and maintain design control documentation
• Develop, update, and maintain risk management and usability files
• Lead optimization of manufacturing and/or R&D processes using Six Sigma and Lean tools
• Lead experiments and tests to create, validate, and improve products and establish robust processes
• Investigate complex product quality and compliance issues and support regulatory submissions

Skills

Six Sigma

Lean manufacturing

Design control

Risk management

Quality systems

Regulatory submissions

Problem solving

Cross-functional teamwork

Education

Bachelor's Degree in Engineering or Scientific field

Master's Degree or equivalent in Engineering or Scientific field

Ph.D. or equivalent in Engineering or Scientific field

Tools

CAD

MS Office Suite

Job description

Edwards Lifesciences in California is seeking a Quality Engineer to lead device design controls, risk management, and manufacturing process optimization within our New Product Development Quality team. You’ll collaborate with engineers, clinicians, and cross-functional teams to ensure compliant, high-quality medical devices that improve patient outcomes.

The role emphasizes leadership, problem solving, and adherence to Edwards’ quality systems, with opportunities to influence product lifecycle