Principal Engineer, Quality

About the role

Edwards' Global Operations & Quality team ensures its cardiovascular devices reach patients safely. As Principal Engineer, Quality, you apply quality engineering principles to ensure compliance with regulatory requirements and the company's systems and procedures, optimizing product development, internal and external device manufacturing and device distribution. You work cross-functionally with manufacturing operations and sales teams.

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 engineers and technicians on testing, train them and provide feedback
• Develop and run complex experiments and tests, write and execute protocols, evaluate source materials and suppliers, and report results
• Create training and documentation materials such as work instructions for production
• Investigate quality and compliance issues (CAPA, non-conformances, audit observations) and lead investigations
• Train and coach lower-level employees, develop risk management file content and manage supplier quality activities as needed

Required profile

• Bachelor's degree in engineering or science with at least 6 years of experience, or a Master's degree with at least 5 years, or a Ph.D. with at least 2 years
• Experience must include either industry or industry/education
• Adherence to Edwards environmental health and safety and quality guidelines for clean room medical device manufacturing

Required skills

• Knowledge of quality engineering principles and methods, including Six Sigma and LEAN
• Statistical techniques and risk management concepts
• Ability to read and interpret drawings (preferred)
• Excellent documentation, communication and negotiation skills
• Ability to work independently, set standards and lead in a team environment