NPD Quality Engineer II: Shape Life-Saving Medical Tech

Edwards Lifesciences Gruppe; United States; On-site; USD 87,000 - 123,000; Full time

Job summary

Edwards Lifesciences in the United States seeks a New Product Development Quality engineer to shape development of breakthrough medical technologies and ensure product integrity throughout the lifecycle.

You will partner with engineers, clinicians, and cross-functional teams to apply quality engineering practices, manage risk, and support regulatory compliance while delivering reliable therapies globally.

Qualifications

• Bachelor's Degree in Engineering or Scientific field with related work experience.
• Master's Degree or equivalent in Engineering or Scientific field with internship/projects.
• Preferred certification in quality engineering (CQE) is a plus.

Responsibilities

• Develop moderately complex experiments and tests with protocols to validate products and manufacturing processes.
• Develop, update, and maintain technical content of risk management files.
• Investigate manufacturing product quality and compliance issues (CAPA, non-conformances, audits).
• Optimize manufacturing processes using engineering methods for design for manufacturing and continuous improvement.
• Develop training and documentation for production to enable knowledge transfer.
• Assign tasks, instruct technicians, provide feedback, and coordinate work.

Skills

CQE (Certified Quality Engineer)

Statistical techniques

Documentation & communication

Team collaboration

Education

Bachelor's Degree in Engineering or Scientific field

Master's Degree or equivalent in Engineering or Scientific field

Job description

Edwards Lifesciences in the United States seeks a New Product Development Quality engineer to shape development of breakthrough medical technologies and ensure product integrity throughout the lifecycle.

You will partner with engineers, clinicians, and cross-functional teams to apply quality engineering practices, manage risk, and support regulatory compliance while delivering reliable therapies globally.