Senior NPD Quality Engineer: Help Shape Life-Saving Devices

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

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Senior Engineer, NPD Quality to drive quality for new product development in cardiovascular devices. You will partner with R&D, Manufacturing, Regulatory, and Clinical teams to ensure design controls, risk management, and reliable product launches.

Responsibilities include maintaining design history files, supporting verification/validation, applying Six Sigma/Lean to improve processes, and mentoring technicians while ensuring FDA and internal

Qualifications

• Bachelor’s or Master’s in engineering/science required or equivalent
• Strong documentation and communication skills are essential
• Experience with design controls and regulatory understanding a plus
• Familiarity with FDA regulations for medical devices preferred
• Ability to lead and train technicians and collaborate cross-functionally

Responsibilities

• Apply quality engineering principles to ensure regulatory compliance and Edwards procedures for new product development
• Maintain design control documentation and support design requirements documentation
• Maintain risk management and usability documentation
• Collaborate with R&D, Manufacturing and other stakeholders to drive process and test method development and product launches
• Investigate complex quality issues during development and recommend corrective actions
• Apply Six Sigma/Lean to optimize processes and equipment for manufacturing and testing

Skills

MS Office Suite

MS Project

CAD

Documentation & Communication

Leadership

Problem-solving

Teamwork

Education

Bachelor’s degree in Engineering or a Scientific field

Master’s degree or equivalent in Engineering or a Scientific field

Tools

CAD experience

Job description

Edwards Lifesciences in Irvine, CA is seeking a Senior Engineer, NPD Quality to drive quality for new product development in cardiovascular devices. You will partner with R&D, Manufacturing, Regulatory, and Clinical teams to ensure design controls, risk management, and reliable product launches.

Responsibilities include maintaining design history files, supporting verification/validation, applying Six Sigma/Lean to improve processes, and mentoring technicians while ensuring FDA and internal