Principal Engineer, Quality

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 youll play a critical role in ensuring every medical device meets the highest standards before reaching patients with cardiovascular disease worldwide. Youll 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 youre 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 youll 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.

How youll make an impact:

• 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.

What youll need:

• Bachelors or Masters 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%.

What else we look for:

• 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.

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.

For California the base pay range for this position is $118000 to $167000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g. qualifications education prior experience).Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role as a condition of employment you will be required to submit proof that you have been vaccinated for COVID-19 unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.