Edwards Lifesciences Quality Engineer II (Post Market Surveillance) - THV in Irvine, California
Looking for a Quality Engineer II to join our growing Transcatheter Heart Valve (THV) business in Irvine, CA. We are looking for a strong engineer with solid technical expertise, who enjoys working in a fast-paced and rapidly growing environment. The engineer will be responsible for driving Post Market Surveillance activities; drafting and creating PSURs (Periodic Safety Update Reports; and involved with DHF (Design History File) audits. This Quality Engineer will also be involved in activities associated with the implementation of the EU Medical Device Regulation (MDR) Program, as needed.
Support the Post-Market Surveillance & Risk Management Review meetings to ensure all activities are completed to maintain the risk management file as new information is learned during the product development process or per signals obtained through post-market surveillance programs.
Develop and maintain Risk Management Files according to ISO 14971 for new or legacy products and ensure Risk Management Files are updated per defined schedules and frequencies. This would include risk management reports, hazard analyses, user risk assessments, design risk assessments and process risk assessments.
Develop and maintain Usability Engineering Files according to ISO 62366 and Human Factors engineering for the legacy products. This would include usability engineering plan, review of and evaluation of historical data and summative evaluation plan.
Provide quality engineering expertise in the areas of Risk Management, Design Controls, Usability Engineering, Quality Assurance/Control, Regulatory Compliance, and Statistical Techniques, as needed.
Ensure compliance with all Federal, State, local and company regulations, policies and procedures.
Performs other quality-related duties as assigned by management.
Basic / Minimum Qualifications:
Bachelor’s degree in Scientific or Engineering field with a minimum of two (2) years of experience within Quality Engineering, Quality Operations, and/or Quality Systems.
Proven experience with Post Market Surveillance, Risk Management, and/or Design Control and Human Factors Usability Engineering programs, processes, or tools.
Medical device industry experience
Experience with sustaining engineering
Knowledge and experience with PSURs (Periodic Safety Update Reports)
Experience with DHF audits
Experience with Class III implantable medical devices.
Knowledge of the Domestic and International regulatory requirements of Medical Device regulations (FDA 21 CFR 820, ISO 13485, ISO 14971; and other applicable regulatory requirements).
ASQ Certified Quality Engineer (CQE), Quality System Lead Auditor, Certified Six Sigma Black Belt (CSSBB), or related quality/regulatory certifications a plus.
Strong attention to detail and ability to recognize problems and take corrective measures.
Demonstrated experience prioritizing conflicting demands in a fast-paced environment.
Critical thinking, strong problem solving, influencing and negotiation skills.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.