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This Principal New Product Development Quality Engineer will be part of Edwards Lifesciences growing Transcatheter Heart Valve (THV) business in Irvine, CA. We are looking for a strong engineer with solid technical expertise, who enjoys working in a fast paced and rapidly growing environment where taking initiative and collaborating cross-functionally are critical for success. This engineer will have a variety of responsibilities in New Product Development providing Quality Engineering support and leadership to ensure the successful design and development of new products.

Key Responsibilities: 

• Apply knowledge of Design Control principles and quality engineering to positively influence new product development efforts, including those for design verification, validation, and specification development.
• Provide quality engineering expertise for new product development programs in the areas of Risk Management, Design Control, Usability Engineering, Statistical Techniques, and Regulatory Compliance as needed.
• Collaborate with R&D to develop design requirements and support design freeze, design verification and validation testing
• Lead test method development and validation activities for new designs
• Lead failure investigations for product failures in design testing and clinical use
• Develop and implement inspection and testing mechanism for components, sub-assemblies, and final assemblies used in new product design and manufacturing
• Develop technical solutions to complex problems, recommend and implement corrective actions, using creativity, statistical techniques, and reliability engineering
• Collaborate with manufacturing and operations team to ensure successful transfer and launch of robust products.
• Ensure compliance with all Federal, State, local and company regulations, policies and procedures.
• Performs other quality-related duties as assigned by management