Principal Engineer, Quality

About the role

Edwards' Global Operations & Quality team works with manufacturing operations and sales to deliver products to patients with cardiovascular disease. The Principal Engineer, Quality applies quality engineering principles and methods to ensure compliance with regulatory requirements and company systems, covering product development, internal and external device manufacturing and device distribution.

Key responsibilities

• Lead the identification and optimization of complex manufacturing processes using engineering methods such as Six Sigma and LEAN, and identify redesign opportunities for equipment, tools and fixtures
• Oversee quality support tasks, instruct and train engineers and technicians, and coordinate their work
• Develop and run complex experiments and tests, write and execute protocols, evaluate source materials and suppliers, and report findings
• Create training and documentation such as work instructions for production
• Investigate quality and compliance issues (CAPA, non-conformances, audit observations) and lead investigations of complex manufacturing problems
• Manage supplier quality activities as needed
• Develop technical content of risk management files and set policies and standards

Required profile

• Bachelor's degree in engineering or science with at least 6 years of experience, or
• Master's degree or equivalent with at least 5 years of experience, or
• Ph.D. or equivalent with at least 2 years of experience
• Experience must include either industry or industry/education

Required skills

• Knowledge of quality engineering principles and methods, including Six Sigma and LEAN
• Ability to read and interpret drawings
• Statistical techniques and documentation and communication skills
• Adherence to environmental health, safety and quality guidelines for clean room medical device manufacturing