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Salary: USD 60,000 - 74,780 / annual
HeartFlow is a publicly traded medical technology company (HTFL) pioneering AI-driven solutions for diagnosing and managing coronary artery disease. The Product Investigator role is a full-time, office-based position in Austin responsible for identifying root causes of product issues and delivering quality, timely reports on product accuracy concerns.
Key responsibilities include conducting thorough investigations on product feature comparisons to Cardiac CTA imaging, identifying root causes related to process, product, or user deficiencies, and completing detailed written reports with supporting cardiac imaging for clinical review. The role requires cross-functional collaboration with Process, Quality, Technology, Training, and Engineering teams to recommend corrective actions and prevent similar accuracy issues. You will support Customer Success and Post-Market Quality teams with customer communication and required regulatory documentation, communicating directly with customers when needed. Additional responsibilities include contributing to team projects focused on efficiency and quality improvements, managing competing assignments, and presenting data and investigation findings to stakeholders.
Required qualifications include a B.S. in biomedical, industrial, mechanical engineering, or equivalent technical field, with minimum 4 years of experience interpreting imaging modalities (Cardiac CTA preferred). Mandatory skills include Cardiac CTA navigation and interpretation, strong written and verbal communication, critical thinking, and root cause analysis expertise. Experience with FDA regulations (21 CFR 820.198, 21 CFR 803, 21 CFR 806) is preferred. Technical proficiency required in Salesforce, Quality Management Systems, Google Suite, DICOM viewers, PowerPoint, and Excel. Experience communicating with physicians, hospital staff, and medical device sales teams is strongly preferred. Root cause analysis experience in the medical device industry is recommended.
