Principal Engineer, Quality
Edwards Lifesciences · Irvine, CA
QualityFull-time$121k–$171kCompany career page
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Role summary
Principal Quality Engineer supporting new product development for transcatheter heart valve devices. Leads design control, risk management, and quality engineering activities from concept through commercialization within a regulated medical device environment.
What they're looking for
- Bachelor's in Engineering or Science with 6+ years experience, or Master's with 5+ years, or PhD with 2+ years
- Design control and risk management experience in medical device or regulated industries
- Knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, ISO 62366 regulations
- Medical device industry experience preferred
- Design assurance expertise including design verification, validation, and test method development
- Leadership experience with direct report management
- ASQ certifications (CQE, CSSBB, Lead Auditor) a plus
What you'll be doing
- Lead quality engineering activities for new product development from concept through launch
- Develop and maintain risk management files and drive design control implementation across projects
- Lead test method development, validation activities, and failure investigations for design and clinical failures
- Manage team of direct reports and develop talent within quality function
- Collaborate with manufacturing and operations on product transfer and robust launch execution
Privacy & handoff
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