Engineer II, Risk Management & Post Market Quality

Edwards Lifesciences • Irvine, CA

3d • $87,000 - $123,000

About The Position

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. 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.

Requirements

• Bachelor’s degree in engineering or scientific field with at least 2 years of experience in medical device risk management
• Knowledge of ISO 14971, ISO 13485, 21 CFR Part 820, EU MDR, and FDA requirements.
• Hands-on experience with design and process FMEA, hazard analysis, and post-market risk assessments.
• Experience assessing complaints, CAPAs, and non-conformances for risk evaluation.

Nice To Haves

• Engineering degree
• Strong analytical and problem-solving skills with attention to detail.
• Excellent communication skills and ability to work cross-functionally in a regulated environment.
• Medical device risk management, preferably in Class III medical devices (e.g., cardiovascular, neurovascular, implantable devices)
• Experience with quality system platforms (e.g., Reliance EQMS, IQVIA or Windchill).
• Experience implementing automation or AI-driven solutions for post market activities.
• Previous experience working with global manufacturing plants and suppliers.
• Six Sigma, or ASQ Certified Quality Engineer (CQE).

Responsibilities

• Develop, maintain, and improve the Risk Management File (RMF) for Class III medical devices, ensuring compliance with ISO 14971, ISO 13485, 21 CFR 820, MDR (EU 2017/745), and other applicable regulations.
• Support regulatory submissions by providing risk documentation for 510(k), PMA, CE Marking, and international registrations.
• Work closely with cross-functional teams (R&D, Regulatory, Clinical, Manufacturing, and Post-Market Surveillance) to ensure risk management principles are integrated into the design and development process.
• Assign Risk IDs for adverse event complaints
• Conduct monthly and quarterly post-market risk assessments by analyzing trends in complaints, adverse events, and field failures to ensure timely mitigation actions.
• Own and author trend memos for complaint trending categories
• Support submissions related to Notification of Change (NOC) by authoring risk assessments
• Drive continuous improvement initiatives by identifying trends and optimizing risk management workflows, templates, and processes.
• Performs other quality-related duties as assigned by management
• Partner with manufacturing plants and process owners to investigate manufacturing non conformances using root cause analysis tools to identify root causes and develop action plans.
• Develop verification and validation plans for corrective actions that are implemented
• Use statistical techniques to determine sample sizes and justification of sample size for effectiveness monitoring

Benefits

• competitive salaries
• performance-based incentives
• a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level