Innovation starts from the heart. Edwards Lifesciences is the leading integral structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Product Quality Clinician position is a unique career opportunity that could be your next step towards an exciting future.
How you will make an Impact:
Provide clinical expert knowledge and clinical guidance to Quality Specialists to understand the nature of complaints and possible health risks.
Provide clinical expert knowledge, clinical data insights and risk evaluation guidance to Quality Specialists to support complaint assessment, trend identification, regulatory decision-making and potential health risk evaluation within Structural Heart therapies.
Analyze and interpret aggregate complaint, clinical and post‑market data for a specific product line, business unit, regulatory submissions,
regulatory agency requests and management reports, including trend identification, visualization and ad hoc analytical summaries.
Provide clinical input to Product Risk Assessments (PRA), utilizing complaint data, clinical trends and predictive risk indicators where appropriate.
Support the development and use of AI‑enabled tools to enhance complaint evaluation, signal detection and quality decision‑making.
Review and interpret relevant imaging information in support of complaint investigations, product quality assessments and risk evaluations.
Develop data visualization tools and dashboards to support quality monitoring, trend detection and management decision‑making.
Support Product Safety in development of clinically based training materials and educate complaint staff to understand the medical aspects of complaint information and associated procedures including health risks.
Provide medical/clinical guidance and final direction