Principal Engineer, Quality

Edwards Lifesciences • Irvine, CA

3d • $118,000 - $167,000

About The Position

Imagine how your ideas and expertise can elevate product quality and transform lives. As part of our Global Quality Manufacturing team within the Global Supply Chain & Quality organization, you’ll play a critical role in ensuring every medical device meets the highest standards before reaching patients with cardiovascular disease worldwide. You’ll collaborate across our many sites with manufacturing operations, engineering, IT, and regulatory teams to tackle complex quality challenges, driving innovation through standardization, process validations, inspection systems, audits, and digital transformation initiatives. If you’re passionate about quality, thrive on problem-solving, and want to make a global impact, join us and help redefine excellence in medical devices. Join our Advanced Quality Engineering Team at Edwards Lifesciences and help shape the future of manufacturing quality! Be part of a team that uses data-driven insights to deliver the highest standards for life-saving medical devices. Your expertise can make a real difference - apply today and help us lead the charge toward the next generation of quality and six sigma outcomes! As a Principal Engineer, you’ll take ownership of complex, hybrid projects, mentor emerging talent, and drive digital quality excellence across our medical device portfolio. Your expertise will ensure compliance, optimize processes, leverage the latest technologies and data strategies, and deliver breakthrough solutions that make a global impact. If you thrive on solving challenges and influencing innovation at scale, this is your opportunity to lead with purpose. The ideal candidate will have a passion for using data to drive impactful decisions, an understanding of database ETL processes (Excel, Power Query, etc.), wireframing of UI, effective testing/investigation, feedback gathering, a solid grasp of types of equipment (Calipers, Pull Testers, Force Gauges, etc.), and technical drawing literacy.

Requirements

• Bachelor’s or Master’s degree in Engineering (Mechanical, Chemical, Biomedical, Bioengineering, or other applied sciences).
• 6 years of experience in medical device engineering or medical device quality roles.
• Travel required ~15%.

Nice To Haves

• Certified Quality Engineer (CQE) or equivalent.
• Excel Certification.
• Measurement and Test Equipment knowledge and experience are essential.
• Process Validation and Software Validation experience.
• Experience with automation, software testing, and software validation.
• Jira experience.
• Comprehensive expertise in Quality Engineering principles and applications (CQE body of knowledge).
• Extensive knowledge of Excel, Power Query, SharePoint Lists, and Microsoft Power Platform.
• Proficiency in CAD tools, simulation software, and quality tools (FMEA, CAPA, statistical analysis).
• Strong experience in structuring data for Big Data applications.
• Knowledge of Python and VBA preferred.
• Experience with UI design best practices, databases, SharePoint, websites, networking, software tools, product design, manufacturing, receiving inspection, and mechatronics.

Responsibilities

• Identify and solve complex problems in a multi-stakeholder, team setting where precedent may not exist, using creativity while maintaining compliance with industry regulations.
• Manage cross-functional projects, timelines, and budgets; implement digital quality tools (eQMS, dashboards).
• Mentor junior engineers and foster a culture of continuous improvement.
• Translate technical information to all levels of the organization through large and small presentations.
• Independently lead QMS improvement activities and associated projects.
• Maintain and improve QMS elements in compliance with FDA QSR, ISO 13485, ISO 14971, and EU MDR.
• Conduct and support internal/external audits as needed and support regulatory submissions when required.
• Own and perform documentation changes and set policies and standards that are followed by others.
• Lead CAPA execution, root cause investigations, and quality data analysis to identify trends.
• Own and drive validation testing (all types), TMV, and software validation testing.
• Lead identification, development, and optimization of complex manufacturing processes using engineering methods (e.g., Six Sigma and Lean tools) for design for manufacturing and continuous process improvement.
• Identify opportunities and implement solutions for re-design/design of complex equipment, new technologies (including automation and software), tools, fixtures, etc., to improve manufacturing processes and reduce risk.
• Drive development and manage execution of complex experiments and tests (including writing and executing protocols) to validate and improve products and establish robust manufacturing processes; ensure completion of process validations (IQ/OQ/PQ), analyze results, and develop reports.

Benefits

• Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees