Quality Engineer I, NPD

Quality Engineer supporting new product development for transcatheter heart valve therapies at Edwards Lifesciences. The role involves optimizing manufacturing processes, developing technical documentation, and collaborating across teams to ensure product quality and safety throughout the development lifecycle.

Responsibilities

• Support design control activities and develop manufacturing documentation including drawings, SOPs, and failure mode analyses
• Create process definitions and develop controls to establish stability metrics and mitigate risks
• Execute experiments, protocols, and validation studies to characterize manufacturing processes
• Collaborate on build strategies, root cause investigations, and process transfer activities
• Apply engineering methods such as LEAN and statistical analysis to drive continuous process improvement

Requirements

• Bachelor's degree in engineering or scientific field
• Proficiency with MS Office Suite and MS Project
• Basic understanding of statistical techniques and engineering principles
• Strong problem-solving, analytical, and critical thinking skills
• Experience with lab or industrial equipment preferred
• CAD experience preferred
• Knowledge of medical device manufacturing and quality guidelines