Senior Quality & Innovation Engineer

Edwards Lifesciences; Irvine, Northern (CA, KY); Hybrid; USD 108,000 - 153,000; Full time

Job summary

Edwards Lifesciences is seeking a Quality Engineering professional to shape design control and risk management across the product lifecycle. You will partner with R&D, manufacturing, and clinical teams to enable safe, effective therapies and drive improvements in design, testing, and verification.

The role emphasizes strong analytical skills, problem-solving, and leadership to guide cross-functional initiatives in a fast-paced medical device environment.

Qualifications

• Bachelor's Degree in Engineering or Scientific field with 4 years of related industry experience
• Master's Degree or equivalent in Engineering or Scientific field with 3 years of related industry or education experience
• Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education

Responsibilities

• Develop, update, and maintain design control documentation through product development processes.
• Collaborate with R&D, manufacturing, and cross-functional stakeholders to drive design transfer and product launch.
• Participate in design verification and validation testing.
• Investigate complex product quality and compliance issues during new product development and analyze results.
• Identify opportunities to optimize manufacturing and RandD processes using SIX Sigma and LEAN methods.
• Train and guide technicians and provide feedback on routine procedures.
• Support leadership with other incidental duties.

Skills

MS Office Suite

CAD experience

Leadership skills

Statistical techniques

Education

Bachelor's Degree in Engineering or Scientific field

Master's Degree or equivalent in Engineering or Scientific field

Ph.D. in Engineering or Scientific field

Tools

MS Project

CAD software

Job description

Edwards Lifesciences is seeking a Quality Engineering professional to shape design control and risk management across the product lifecycle. You will partner with R&D, manufacturing, and clinical teams to enable safe, effective therapies and drive improvements in design, testing, and verification.

The role emphasizes strong analytical skills, problem-solving, and leadership to guide cross-functional initiatives in a fast-paced medical device environment.