Principal Clinical QA Specialist

Elucid•Boston, MA

72d•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! As a Principal Clinical Quality Assurance Specialist, you'll play a pivotal role in ensuring our cardiovascular imaging software is developed with the highest standards of safety, reliability, and clinical precision. You'll lead high-impact cross-functional initiatives, shape testing strategies, and guide other CQA members in upholding excellence, compliance, and innovation at every step. Drawing on your expertise in medical imaging and software testing, you'll help bring groundbreaking cardiovascular imaging software to life, advancing care for clinicians and their patients. If you're driven by quality, collaboration, and the chance to pioneer the future of cardiovascular diagnostics, we want you on our team!

Requirements

6+ years experience in clinical software quality assurance or medical device testing, with proven success in developing and executing large-scale test strategies and driving process improvements within a regulated industry.
Demonstrated ability to lead cross-functional teams, manage multiple complex projects, and make risk-based decisions to ensure high-quality outcomes in a fast-paced startup environment.
Strong mentoring and leadership skills, with a track record of supporting professional development and technical growth of team members.
Excellent communication, collaboration, and decision-making skills, capable of influencing stakeholders across departments and organizational levels.
Solid understanding of regulatory standards (e.g., FDA, ISO 13485, IEC 62304) and their application to clinical software testing and quality processes.
Advanced degree or equivalent work experience in Biomedical Engineering, Computer Science, Bioengineering, Radiology Technology, or a closely related technical field.