Senior Quality Engineer, Risk Management & Product Risk Assessment

Edwards Lifesciences; Irvine (CA); On-site; USD 106,000 - 149,000; Full time

Job summary

A leading company in medical devices seeks a Senior Quality Engineer to manage risk assessment activities for their Transcatheter Heart Valve unit. The role involves compliance with ISO standards and collaboration with cross-functional teams to enhance patient care. Ideal candidates have a strong engineering background and experience in medical device risk management.

Benefits

Competitive salaries

Performance-based incentives

Wide variety of benefits programs

Qualifications

• At least 4 years of experience in medical device risk management.
• Strong knowledge of ISO 14971, ISO 13485, and FDA requirements.

Responsibilities

• Develop and maintain the Risk Management File for Class III medical devices.
• Conduct post-market risk assessments by analyzing trends in complaints.

Skills

Analytical Skills

Problem-Solving

Communication

Education

Bachelor's degree in engineering or scientific field

Master's degree in engineering or scientific field

Tools

MedDev

Greenlight Guru

SAP

Windchill

Job description

Please note this is an "onsite" role, and the successful candidate will be expected to work at our corporate Irvine, CA campus.

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 Senior Quality Engineer will be part of Edwards Lifesciences’ growing Transcatheter Heart Valve (THV) quality engineering team in Irvine, CA. This position is responsible for managing THV’s Risk Management/Product Risk assessment activities and contributing to Post-Market Surveillance. We are looking for a strong engineer with solid technical expertise, who enjoys working in a fast-paced and rapidly growing environment.

How you will make an impact :

• Risk Management System & Compliance
  • 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.

• Product Risk Assessment (PRA) for Manufacturing & Complaints
  • Maintain a structured business process for Product Risk Assessment (PRA) related to manufacturing non-conformances and customer complaints.
  • Partner with manufacturing plants to assess risk impact of process deviations, supplier issues, and product failures.
  • Develop and implement risk escalation procedures for critical failures and field safety actions.
    Improve efficiency in identifying and assigning risk IDs for complaints by introducing automation or AI-based solutions where applicable.

• Post-Market Surveillance & Continuous Improvement
  • Conduct post-market risk assessments by analyzing trends in complaints, adverse events, and field failures to ensure timely mitigation actions.
  • Support risk-based decision-making for design changes, field actions, and recalls in collaboration with Clinical, Regulatory, and Quality teams.
  • Drive continuous improvement initiatives by identifying trends and optimizing risk management workflows, templates, and processes.
  • Provide training to internal teams on risk management methodologies, regulatory expectations, and best practices.
  • Performs other quality-related duties as assigned by management

What you’ll need (Required) :

• Bachelor’s degree in engineering or scientific field with at least 4 years of experience in medical device risk management; or Master’s degree in engineering or scientific field with at least 3 years of experience in medical device risk management.
• Strong 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.
• Strong analytical and problem-solving skills with attention to detail.
• Excellent communication skills and ability to work cross-functionally in a regulated environment.

What else we look for (Preferred):

• Engineering degree
• Medical device risk management, preferably in Class III medical devices (e.g., cardiovascular, neurovascular, implantable devices)
• Experience with risk management software tools (e.g., MedDev, Greenlight Guru, SAP, or Windchill).
• Experience implementing automation or AI-driven solutions for complaint risk assessments.
• Previous experience working with global manufacturing plants and suppliers.
• Six Sigma, or ASQ Certified Quality Engineer (CQE).

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 $106,000 to $149,000 (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.