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.
This Quality Engineer will support, perform, and/or complete assigned complaint investigations that include (but are not limited to) Product Failure Analysis and complaint documentation review (device history record, complaint history, products instructions, risk management, etc.), and prepare technical investigation reports.
How you will make an impact:
- Investigate manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
- Perform assessment for similar incident reportable complaints to identify rate and possible escalation.
- Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed.
- Participate in escalation tasks and activities, including Project Risk Assessments (PRA) and Corrective/Preventive action(s) – CAPAs, SCARs, as determination by investigation.
- Identify and report key complaint metrics per device category and collaborate with applicable manufacturing engineering teams to resolve production/device related issues.
- Assist in ad hoc complaint analysis or metric review.
- Perform other duties and responsibilities as assigned.
What you’ll need:
- Bachelor's in Engineering or Scientific field.
What else we look for:
- Medical Device, Pharma, Biotech, or other Lifesciences industry experience.
- Experience with product or device complaints, investigations, and/or root cause analysis.
- Experience with NCRs, FMEAs, CAPAs, or Product Risk Assessments.
- Familiar with key technologies and processes related to the assembly and manufacture of Class III cardiovascular devices and delivery systems.
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 $67,000 to $96,000 (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.
What We Do
Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more.
Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today.
Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives.
Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life.
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