Senior Quality Engineer - Medical Devices & Innovation

Edwards Lifesciences Gruppe; United States; On-site; USD 121,000 - 171,000; Full time

Benefits offered by this job

Competitive salary

Performance incentives

Benefits programs

Job summary

Edwards Lifesciences is seeking a New Product Development Quality engineer to lead design control documentation, risk management, and process improvements across R&D and manufacturing. You will collaborate with engineers, clinicians, and cross-functional teams to enable safe, effective, and reliable therapies through rigorous quality practices.

This role requires deep expertise in quality engineering, regulatory compliance, and continuous improvement methods, with a focus on medical device

Qualifications

• Bachelor's, Master's, or PhD in Engineering/Scientific field with relevant experience.
• Ability to apply quality engineering principles to enable innovation while ensuring regulatory compliance.

Responsibilities

• Provide leadership and oversight for a device, system, or project to develop, update, and maintain design control documentation.
• Develop and maintain risk management and usability files.
• Lead manufacturing/RTD process improvements using Six Sigma and Lean tools.
• Plan and execute complex experiments and tests with protocol development and validation.
• Investigate complex product quality and compliance issues and support audits and regulatory submissions.
• Coach and guide engineers/technicians on complex procedures and tests.

Skills

Leadership

Six Sigma

Lean manufacturing

Quality engineering

Design control

Risk management

Engineering principles

Education

Bachelor's Degree in Engineering or Scientific field

Master's Degree or equivalent in Engineering or Scientific field

Ph.D. or equivalent in Engineering or Scientific field

Tools

CAD

MS Office Suite

Job description

Edwards Lifesciences is seeking a New Product Development Quality engineer to lead design control documentation, risk management, and process improvements across R&D and manufacturing. You will collaborate with engineers, clinicians, and cross-functional teams to enable safe, effective, and reliable therapies through rigorous quality practices.

This role requires deep expertise in quality engineering, regulatory compliance, and continuous improvement methods, with a focus on medical device