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About the Role

The Product Investigator role identifies the root cause of product issues and delivers quality, timely reports on product accuracy concerns when compared to Cardiac CTA. This role ensures thorough review, investigation, documentation, and reporting of potential accuracy concerns in compliance with regulatory and FDA requirements.

Responsibilities

• Conduct investigations on product feature comparisons to Cardiac CTAs and review questions and allegations to accurately identify root causes as well as potential process, product, and/or user deficiencies.
• Complete thorough written reports with supporting Cardiac CTA images for presentations appropriate for review with Clinicians.
• Support Customer Success and Post-Market Quality teams with Customer communication and required documentation.
• Communicate directly with Customers when needed.
• Work cross-functionally with multiple teams (Process, Quality, Technology, Training, Engineering, etc.) and recommend corrective actions required to address identified root causes and prevent similar accuracy issues.
• Contribute to and participate in team project definition and execution related to efficiency and quality improvements.
• Self-manage task list and competing assignments to deliver completed investigations in a timely manner.

Requirements

• Experience with Cardiac CTA navigation and interpretation is mandatory.
• Experience communicating with Physicians, hospital staff, and Medical Device Sales Teams is strongly preferred.
• Strong written and verbal communication, documentation, and problem-solving skills.
• Experience developing processes is required.
• Expertise in the ability to apply critical thinking and utilize various Root Cause Analysis techniques.
• The ability to learn quickly, self-lead, work well with others, and manage a task list is necessary.
• Understanding of FDA regulations for compliance (21 CFR 820.198, 21 CFR 803, 21 CFR 806) is preferred.
• Strong skills using SalesForce, Quality Management Systems, Google Suite, DICOM viewers, PowerPoint, and Excel for documentation and data presentation are needed.

Skills

• Cardiac CTA navigation
• Cardiac CTA interpretation
• Physician communication
• Hospital staff communication
• Medical Device Sales Team communication
• Written communication
• Verbal communication
• Documentation
• Problem-solving
• Process development
• Critical thinking
• Root Cause Analysis techniques
• Quick learning
• Self-leadership
• Teamwork
• Task management
• FDA regulations compliance
• SalesForce
• Quality Management Systems
• Google Suite
• DICOM viewers
• PowerPoint
• Excel

Work Type

• Full-time

Experience Level

• Minimum of 4 years of experience with interpreting an imaging modality; Cardiac CTA preferred.
• Root cause analysis related work experience in the medical device industry recommended.

Education Level

• B.S. in biomedical, industrial, and/or mechanical engineering or other technical field, or equivalent in related experience.

Salary/Compensations

• $60,000 to $74,780

About the Company

• Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology.
• The flagship product—an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis—provides a color-coded, 3D model of a patient’s coronary arteries indicating the impact blockages have on blood flow to the heart.
• Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMap™Analysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis).
• Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare.
• Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 500,000 patients worldwide.

Equal Opportunity

• Heartflow is an Equal Opportunity Employer.
• We are committed to a work environment that supports, inspires, and respects all individuals and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
• This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination.