This position is designated as onsite at our Irvine, CA campus. However, hybrid or remote work flexibility may be available on a periodic basis.  

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

The Senior Principal Quality Engineer will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to drive large scale comprehensive investigations across multiple sites, interfacing with internal and external partners. They will be a key partner is leveraging the learnings from those investigations to drive long term improvements in device manufacturing, design, and distribution.

How you will make an impact:

Initiate and lead in the investigation of highly complex product quality and compliance issues (e.g., PRAs, CAPA, non-conformances, audit observations) for all production processes based on engineering principles; analyze results, make recommendations and develop reports, based on engineering principlesDrive the development and manage the execution of multiple, highly complex experiments and tests (including writing and executing protocols) to assess impact, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports and lead team members to drive investigations to completion.Lead in the identification and ensure the optimization of highly complex processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of highly complex equipment, tools, fixtures, etc. to improve processes, and reduce risk.Develop training and documentation materials (e.g., work instructions) to enable seamless knowledge transfer of project, manufacturing, and business processes.Oversee Quality support tasks; give instruction to engineers/technicians on conducting tests; train engineers/ technicians and provide feedback; and may coordinate engineers/ technician work. Train, coach, and guide lower-level employees on highly complex procedures.May be selected as an Independent Reviewer for design reviews.Lead training, new system procedures, and new method development
 

What you’ll need (Required):

Bachelor’s degree in engineering or scientific field, plus at least (8) years of experience with either Quality Engineering, Product Investigations, and/or Risk Management; ORMaster’s degree in engineering or scientific field, plus at least (7) years of experience with either Quality Engineering, Product Investigations, and/or Risk ManagementProven experience leading cross-functional root cause investigations and Product Risk Assessments (PRAs)Experience and strong knowledge of CAPA, NCR, and complaint investigation processesExcellent communication skills and documenting complex information

What else we look for (Preferred):

Engineering degreeDemonstrated ability to drive investigations across multiple sites and functional groupsAbility to lead and train teams on Root Cause Analysis (RCA) methodologiesExperience implementing systemic quality improvements across global sitesWorking knowledge of process and equipment validationsFamiliarity with FDA 21 CFR 820, ISO 13485, and ISO 14971Experience with Class III medical devices or implantable technologiesFamiliarity with tools like TrackWise, Greenlight Guru, or WindchillSix Sigma Black Belt or equivalent certification

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 (CA), the base pay range for this position is $136,000 to $192,000 (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.