Quality Engineer I

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.  Edwards Lifesciences has a unique entry level opportunity that will play a critical role in the growth of cutting-edge heart valve therapies for Transcatheter Mitral & Tricuspid Valve repair. This Quality Engineer will apply knowledge of technical principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

How you will make an impact:
• Investigate product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
• Communicate and present relevant investigation results and findings to team and management.
• Participate in and support escalation tasks and activities, including Product Risk Assessments (PRAs) and Corrective/Preventive action(s) (CAPAs) as determined by investigation.
• Support design verification activities while maintaining regulatory and quality compliance.
• Identify and report key complaint metrics per device category and collaborate with applicable R&D, clinical development, and manufacturing engineering teams to investigate and resolve device related issues.
• Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed.
• Support, update, and maintain technical content of risk management files.
• Support development of experiments and tests with limited complexity (including writing and executing protocols) to investigate issues and improve products and manufacturing methods based on engineering principles; analyze results, make recommendations, and develop reports
• Support other incidental duties assigned by Leadership

What you'll need (Required):
•    Bachelor's Degree in Engineering or scientific field

What else we look for (Preferred):
• Relative internship, cohort or other medical device industry experience 
• Demonstrated understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Professional proficiency level computer skills in usage of MS Office Suite (Outlook, Word, Excel, Power Point)
• Ability to manage competing priorities in a fast paced environment
• Basic or foundational understanding of statistical techniques
• Proficient documentation, communication and interpersonal relationship skills
• Demonstrated problem-solving, analytical and critical thinking skills
• Knowledge of and adherence to Quality systems
• Ability to thrive in a team environment, and interact professionally with all organizational levels
 

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 $69,000 to $98,000 (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.