Principal Engineer, NPD-Quality

Principal Engineer for New Product Development Quality at Edwards Lifesciences, responsible for leading quality engineering oversight across device development, risk management, and manufacturing processes. Role involves design control documentation, process optimization, regulatory compliance, and cross-functional collaboration to bring cardiac surgical innovations to market.

Responsibilities

• Lead development and maintenance of design control documentation and design requirement files throughout product development
• Develop and oversee risk management and usability documentation for medical devices
• Drive process optimization initiatives using Six Sigma and Lean manufacturing tools for manufacturing and R&D
• Design and execute complex experiments, protocols, and validation studies to establish robust processes and test methods
• Investigate product quality and compliance issues; conduct root cause analysis and support regulatory submissions

Requirements

• Bachelor's degree in Engineering or Scientific field with 6+ years industry or combined industry/education experience
• Master's degree in Engineering or Scientific field with 5+ years relevant experience, or Ph.D. with 2+ years
• ASQ Certified Quality Engineer (CQE) certification preferred
• Proficiency with MS Office Suite and CAD software
• Advanced problem-solving, analytical, and critical thinking skills
• Strong leadership and ability to influence organizational change
• Knowledge of medical device manufacturing, clean room environments, and quality systems