Senior Engineer, NPD Quality
$108k - $153kEdwards Lifesciences Corp.
Edwards Lifesciences seeks a Senior Quality Engineer for new product development in transcatheter heart valve devices. The role involves quality engineering leadership across design control, risk management, and regulatory compliance throughout the product development lifecycle in Irvine, California.
Responsibilities
- Develop and maintain design control documentation and design requirement specifications
- Create and update risk management and usability assessment files throughout development
- Investigate product quality issues, non-conformances, and compliance gaps with engineering analysis
- Lead design verification and validation testing with cross-functional teams
- Optimize manufacturing and R&D processes using Lean and Six Sigma methodologies
Requirements
- Bachelor's degree in Engineering or Science with 4+ years related industry experience
- Master's degree in Engineering or Science with 3+ years related industry experience (alternative)
- Ph.D. in Engineering or Science with industry experience (alternative)
- FDA regulations knowledge for medical device industry
- Proficiency with MS Office Suite and project management tools
- Statistical analysis and problem-solving capabilities
- Leadership and cross-functional collaboration skills
Compensation: $108,000 - $153,000 base
Vacancy posted 12 days ago
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