Product Investigator (Office Based)
Summary
Investigates medical device accuracy issues by analyzing cardiac CT scans and ensuring compliance with FDA regulations, collaborating with cross-functional teams to improve product quality.
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.
The Product Investigator role is a full-time position that identifies the root cause of product issues and requires delivery of quality and timely reports relating to product accuracy concerns when the results are compared to Cardiac CTA. This role ensures that any reported potential accuracy concerns are thoroughly reviewed, investigated, documented, and reported on, in compliance with regulatory and FDA requirements and obligations (e.g., 21 CFR 820.198, 21 CFR 803, 21 CFR 806).
The Product Investigation Team supports company goals for timeliness of complaint investigations both to comply with FDA expectations and to communicate with our customers. Additionally, the team collects data and identifies trends and communicates with cross-functional teams to reduce the complaint rate and improve product accuracy. Regular review and presentation of the data and investigation findings is required.
Job 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 be able to recommend corrective actions required to address identified root causes and prevent similar accuracy issues as needed.
- 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.
Skills Needed:
- 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 as well as experience developing processes is required.
- Must have 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.
Educational Requirements & Work Experience:
- B.S. in biomedical, industrial, and/or mechanical engineering or other technical field, or equivalent in related experience.
- 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.
A reasonable estimate of the yearly base compensation range is $60,000 to $74,780. #LI-IB1