Edwards Lifesciences Principal Quality Engineer – Risk Management (Transcatheter Heart Valve) in Irvine, California
This Principal Quality Engineer will be part of Edwards Lifesciences growing Transcatheter Heart Valve (THV) business unit sustaining team in Irvine, CA. This position is responsible for leading and managing THV’s Sustaining Risk Management team and contributing to the Post-Market Surveillance.
Oversee and coordinate junior level engineers’ work; train and give instruction to engineers on continuous updates of Risk Management Files for THV commercially available devices
Core Team member and ownership of Risk Management activities on design projects for commercially available devices (e.g. expanded indications, access routes, design, or manufacturing changes)
Lead and work closely with the Corporate Product Safety, Clinical Development, and Quality Engineering teams in the drafting and updating benefit risk discussions for residual risks
Lead Risk Management activities for regulatory submissions
Serve as a THV Risk Management expert to global manufacturing sites for adequate process risk identification mitigation, and linkage to Risk Management
Support Post Market Surveillance annual reviews and input to PSURs per EU MDR
Guides others in resolving complex issues in Risk Management area based on existing solutions and procedures and provides solutions which are highly innovative and creative
Other responsibilities may be assigned
Minimum Education & Experience:
Bachelor's Degree in Engineering or Scientific field with a minimum of 8 years of experience with Quality Engineering, Quality Operations, and/or Quality Systems; or Master's Degree in Engineering or Scientific field, with a minimum of 7 years of the aforementioned experience
In-depth experience and familiarity with Medical Device Risk Management Process per ISO 14975 and EU MDR requirements
Demonstrated leadership experience
Experience creating, authoring, and approving risk management documents; and strategizing on risk management activities
Experience or involvement with Sustaining and/or New Product Development projects/initiatives highly preferred
Strong leadership skills and ability to influence change and challenge status quo with respect to opportunities for improvement
Makes decisions in the face of different alternatives and without or with guidelines
Direction tends to be high level and focused on end results
Determines or effectively recommends course of action after considering potential risks of alternatives
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
Ability to translate complex and technical information to all levels of the organizations
Expertise in applying Quality Engineering concepts (e.g., CQE body of knowledge) with the ability to lead projects utilizing these principles
Advanced problem-solving, organizational, analytical and critical thinking skills
Ability to manage competing priorities in a fast-paced environment
Work is generally self-guided with adherence to established patterns and practices
Identifies technical gaps and takes action to address them
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 15,000 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.