Senior Clinical Validation Engineer

Elucid•Boston, MA

47d•$140,000 - $165,000•Hybrid

About The Position

We are a rapidly growing, Boston-based medical technology company using AI to enable clinicians to make informed decisions on cardiovascular care - leading to better patient outcomes, improved quality of care, and reduced healthcare costs. Come work at Elucid and be part of delivering on our mission to prevent heart attacks and strokes. Join our growing Clinical QA team ensuring our medical device software meets the highest standards of clinical accuracy and regulatory compliance! Our CQA team collaborates across software development, quality, clinical and regulatory teams, acting as quality advocate on behalf of patient and physician needs throughout the software development lifecycle. As a Senior Clinical Validation Engineer, you'll be at the forefront of advancing our AI-powered cardiovascular imaging software. In this role, you'll lead validation for major system enhancements and new product launches, ensuring our software meets the highest standards of clinical performance and regulatory compliance. Leveraging your expertise in SaMD validation, medical device regulation, and cardiovascular imaging, you'll drive cross-functional initiatives, oversee rigorous testing and documentation, and serve as a trusted subject matter expert. Your work will play a key role in delivering a safe, effective, and potentially life-saving solution empowering physicians and transforming patient care.

Requirements

Degree in biomedical engineering, radiology technology, computer science or related field with 5+ years of SaMD validation or clinical QA experience. or, Advanced degree in a related field with 3+ years of relevant experience.
Excellent communication, collaboration, and decision-making skills, with the ability to translate complex technical concepts into clear, accessible language and influence stakeholders across diverse teams and organizational levels.
Demonstrated ability to guide cross-functional teams, manage multiple complex projects, and make risk-based decisions to ensure high-quality outcomes in a fast-paced startup environment.
Strong understanding of medical software systems, applicable regulatory standards, and their integration into clinical workflows.
Prior experience working with with medical imaging (CTA), AI-enabled clinical software, or cardiovascular diagnostics.
Strong experience using Jira.
Knowledge of cardiovascular disease and anatomy.