Senior Medical Device Quality Engineer

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

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Quality Engineer to strengthen New Product Development Quality. You will develop, update and maintain design control documentation to support product development and risk management throughout the lifecycle.

Collaborate with R&D, manufacturing, and clinical teams to enable design verification/validation, process improvements, and compliant product launches. A strong engineering degree and 4+ years of related experience are expected.

Qualifications

• Bachelor's degree required; 4 years' related industry experience.
• Master's or PhD preferred with related industry or education experience.
• Strong documentation, communication and leadership capabilities.

Responsibilities

• Develop, update and maintain design control documentation through product development.
• Collaborate with R&D, manufacturing and cross-functional teams on design transfer and validation.
• Investigate quality issues, drive risk management and process improvements.

Skills

Problem solving

Communication skills

Leadership

Statistical techniques

Process improvement

Team collaboration

Education

Bachelor's degree in Engineering or Scientific field

Master's degree or Ph.D. in Engineering or Scientific field

Tools

MS Office Suite

MS Project

CAD

Job description

Edwards Lifesciences in Irvine, CA is seeking a Quality Engineer to strengthen New Product Development Quality. You will develop, update and maintain design control documentation to support product development and risk management throughout the lifecycle.

Collaborate with R&D, manufacturing, and clinical teams to enable design verification/validation, process improvements, and compliant product launches. A strong engineering degree and 4+ years of related experience are expected.