Senior Quality Engineer, NPD – THV Innovation

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

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Principal Quality Engineer for New Product Development within the Transcatheter Heart Valve unit. You will lead quality engineering efforts to ensure successful design and development of new products, complying with regulatory requirements and Edwards' systems.

You will partner with R&D, manufacturing, and clinical teams to drive risk management, design verification, and validation activities, while applying Six Sigma and LEAN methods to improve

Qualifications

• Bachelor's degree in Engineering or Scientific field with 4 years’ related industry experience; or
• Master's degree or equivalent with 3 years' related industry experience; or
• Ph.D. or equivalent with industry experience.

Responsibilities

• Develop, update, and maintain design control documentation through product development processes.
• Collaborate with R&D, manufacturing, and cross-functional stakeholders to drive process and test method development, product builds, clinical programs, design transfer, and product launch.
• Investigate complex product quality and compliance issues during new product development; analyze results and develop reports.
• Apply Six Sigma and LEAN methods to optimize design for manufacturing and continuous improvement; identify redesign opportunities.
• Assign support tasks; train and guide technicians on routine procedures and testing; supervise trainee staff.
• Perform other duties as assigned by leadership.

Skills

MS Office

MS Project

CAD

Documentation

Communication

Statistics

Leadership

FDA knowledge

Education

Bachelor's degree in Engineering/Science

Master's degree

PhD in Engineering/Science

Tools

CAD

MS Project

MS Office

Job description

Edwards Lifesciences in Irvine, CA is seeking a Principal Quality Engineer for New Product Development within the Transcatheter Heart Valve unit. You will lead quality engineering efforts to ensure successful design and development of new products, complying with regulatory requirements and Edwards' systems.

You will partner with R&D, manufacturing, and clinical teams to drive risk management, design verification, and validation activities, while applying Six Sigma and LEAN methods to improve