Manufacturing Engineer II, Transfer Engineering

Manufacturing Engineer II will lead product transitions into manufacturing for transcatheter heart valve devices, optimizing processes through process improvement methodologies, conducting experiments for validation, and resolving manufacturing issues. The role involves cross-functional collaboration with operations and sales teams at Edwards Lifesciences' Salt Lake City facility.

Responsibilities

• Optimize manufacturing processes using engineering methods and design improvements for equipment and fixtures
• Develop and execute experiments and protocols to qualify and validate manufacturing processes
• Analyze and resolve manufacturing and compliance issues including CAPAs and non-conformances
• Create training materials and work instructions to transfer manufacturing knowledge to production teams
• Establish project plans and manage timelines using project management tools

Requirements

• Bachelor's degree in engineering or scientific field with 2+ years related experience
• Master's degree in engineering or scientific field with industry or combined industry/education experience
• Process validation experience or exposure
• Proficiency with MS Office Suite, MS Project, and CAD software
• Knowledge of FDA regulations for medical device manufacturing
• Understanding of statistical techniques and SIX Sigma/LEAN methodologies
• Strong written and verbal communication skills