Quality Engineer II

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 is excited to open this position for a first-to-market tricuspid transcatheter replacement system (EVOQUE). This is a unique opportunity to join an innovative team to work on a revolutionary, novel device within Edwards Transcatheter Mitral & Tricuspid Therapies business unit. TMTT is dedicated to lead and transform treatment for patients with mitral and tricuspid valve disease. Working on the TMTT Commercial Quality team, the Quality Engineer II will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product adoption, internal and external device manufacturing, and device distribution. 

How you will make an impact: 

• Investigate complex product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
• Participate in and own escalation tasks and activities, including Project Risk Assessments (PRAs) and Corrective/Preventive action(s) (CAPAs) as determined through investigation.
• Ensures changes to products are developed and manufactured in accordance within regulations and design requirements
• 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.
• Update and maintain technical content of risk management files.
• Support development of moderately complex experiments and tests (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
• Other incidental duties assigned by Leadership

What you'll need (Required):

• Bachelor's Degree or equivalent in in Engineering or Scientific field, 2 years’ experience related work experience OR
• Master's Degree or equivalent in and internship, senior projects or thesis in Engineering or Scientific field including either industry or industry/education.

What else we look for (Preferred):

• Proven expertise in usage of MS Office Suite including MS Project
• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Strong problem-solving, organizational, analytical and critical thinking skills
• Experience with medical devices and knowledge of applicable FDA regulations for medical device industry
• Strict attention to detail
• Complaints investigation experience and/or hands-on experience with device investigations
• Basic understanding of statistical techniques

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 $83,000 to $117,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

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 $83,000 to $117,000 (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.