Jobs at Heartflow

Own the multi-year strategy and roadmap for a portfolio of FDA-regulated, AI-driven cardiovascular medical products. Define product requirements, performance targets, intended use, evidence and regulatory strategies, and care-pathway integration. Lead cross-functional alignment across engineering, clinical, regulatory, quality, UX, marketing, and support without formal authority. Engage physicians, health systems, and key opinion leaders while communicating portfolio risks and progress to executives. The role requires deep medical-device product management experience, cardiovascular or diagnostic expertise, and strong validation and regulatory judgment.

Own research data campaigns for medical imaging AI, including campaign design, annotation workflows, schema and ontology validation, quality measurement, reproducibility, and dataset documentation. Partner with data scientists, research scientists, engineering, clinical, product, and regulatory teams to translate research needs into reliable datasets. Build and validate pipelines using Python and SQL, coordinate timelines and resources, and ensure data quality supports algorithm development and product decisions.

Lead the migration of AWS Lambda and ECS/Fargate workloads to Kubernetes on AWS EKS. Define migration roadmaps and reference architectures, build infrastructure with Terraform, Terragrunt, and Helm, develop event-driven workflows, and partner with engineering teams on standardized migration tooling. Optimize performance, cost, reliability, security, and developer experience through benchmarking, resource tuning, observability, documentation, and operational guardrails.

Partner with engineers on secure SDLC activities, including secure code reviews, threat modeling, vulnerability remediation, security testing, and risk assessment. Drive SAST, DAST, SCA, AI-assisted security testing, and external penetration testing. Translate security and privacy requirements into technical requirements, train teams on secure coding, and address modern AI security threats in a regulated healthcare environment.

Lead the strategy, execution, oversight, and continuous improvement of Heartflow’s global Quality Management System. Manage CAPA, document control, training, audits, management reviews, tool validation, and supplier management. Serve as the QMS subject matter expert during FDA, Notified Body, and other regulatory audits. Lead and develop a quality team, promote a quality-first culture, drive KPI-based decisions, and collaborate with R&D, Production, Regulatory, Clinical, and Product Management teams to support compliant global expansion.

Build and architect a production-grade Agentic AI platform for autonomous medical reasoning, initially serving as a hands-on technical lead. Establish orchestration, state management, tools, memory, guardrails, evaluation, and compliance frameworks. Transition into managing and scaling an engineering team, setting technical strategy, delivering AI-driven products, and collaborating with product, clinical, and data science teams. Ensure secure, accurate, deterministic, and FDA-compliant software through strong engineering, testing, logging, and deployment practices.

Lead software quality and design excellence for AI/ML-enabled medical devices and SaMD. Oversee design controls, QMS integration, risk management, software verification and validation, Design History Files, design transfer, regulatory submissions, and audit readiness. Advise on architecture, cybersecurity, privacy, Agile compliance, and validation frameworks for cloud infrastructure and AI/ML. Serve as a global quality subject matter expert while mentoring engineering, product, and program teams.

Architects and leads end-to-end test automation for regulated Software as a Medical Device products. Owns automation frameworks, AI-assisted testing, post-deployment verification, tool validation, API and integration testing, CI/CD integration, traceability, audit evidence, and root-cause investigations. Establishes testing standards across frontend, backend, 3D visualization, desktop, and AI/ML systems while partnering with engineering and regulatory teams. Mentors engineers, supports audits and submissions, and shapes the growth of the Test Engineering function.

Designs and owns end-to-end automated testing across UI, APIs, back-end services, ML pipelines, and clinical workflows for regulated SaMD products. Builds smoke, regression, visual, post-deployment, and integration tests using Selenium and Playwright; validates tools under medical-device QMS requirements; supports CI/CD, audits, CAPAs, traceability, defect resolution, and regulatory submissions. Coordinates offshore contractors, mentors engineers, and collaborates with engineering, product, and RA/QA teams.

Own the architecture and operation of Heartflow’s production OLTP databases supporting clinical and operational applications. Design schemas and data models, optimize queries, improve database performance and reliability, and guide Django ORM and backend data-access practices. Lead database operations, compliance, security, privacy, recovery, observability, and incident response across AWS. Mentor engineers and influence cross-team architecture, while supporting healthcare data standards, analytics pipelines, data lakes, and AI-oriented semantic data structures.

Design and build scalable interoperability services connecting hospital EHR systems with AWS cloud services. Develop clinical data models, ingestion pipelines, secure REST APIs using FHIR and HL7, and resilient distributed systems. Ensure compliance with FDA and HIPAA standards, lead testing strategies, contribute to architecture, and mentor junior engineers.

Lead data strategies bridging research and production ML for medical imaging. Define data/annotation campaigns, architect curation and management systems, partner with MLOps, build evaluation frameworks, and perform statistical analyses to improve AI model performance across patient populations while driving cross-functional alignment.

Lead systems engineering for Heartflow's plaque analysis products: define system requirements and architecture, establish ground-truth and measurement-accuracy strategies, drive V&V and regulatory documentation, curate plaque datasets, investigate plaque-related issues, manage technical risk, and collaborate cross-functionally with Algorithm, Software, Clinical, Regulatory, and Quality teams to validate and improve plaque characterization.

Manage and coordinate multiple cross-functional software and medical product development projects at the program level. Lead planning, execution, dependency management, communication, and team accountability. Ensure programs align with business priorities, support audits and regulatory traceability, resolve complex issues, and drive process improvements to deliver regulated SaaS/SaMD products on time and within budget.

Lead software quality and design control for SaMD and AI/ML-enabled digital health products. Manage end-to-end SDLC design controls, risk analyses (HA, FTA, FMEA), and software V&V. Ensure regulatory compliance (IEC, ISO, AAMI), maintain audit-ready DHF, support global submissions (FDA, PMDA, EU-MDR), and coach R&D on quality and compliance within an Agile SaaS environment.

Drive adoption and growth of Heartflow's cCTA/FFRct clinical pathway within assigned accounts by building relationships with cardiologists and referring physicians, executing business development plans, coordinating cross-functional resources, delivering education and presentations, organizing outreach programs, and meeting quota and usage-growth targets.

Lead and coordinate complex cross-functional software and release projects, enforce design controls and audit readiness (FDA, QMSR), manage Jira for traceability, implement automation using LLMs/AI and low-code tools, mitigate risks and dependencies, mentor teams, and ensure projects align with program objectives and regulatory requirements.

Lead multiple cross-functional program teams through end-to-end lifecycle of complex, regulated initiatives. Define strategy, timelines, resources, risk and contingency plans; align stakeholders and executives; drive delivery on time and on budget; resolve conflicts; and coach teams to build accountability and continuous improvement.

Leads regional customer success and implementation teams delivering Heartflow’s diagnostic platform across healthcare organizations. Oversees execution, quality, KPIs, customer adoption, escalations, cross-functional alignment, process improvement, resource planning, and talent development. Partners with commercial, sales, reimbursement, medical affairs, product, quality, and regulatory stakeholders while explaining medical technologies to physicians and hospital leaders. Requires healthcare implementation experience, strong operational leadership, and extensive people-management experience.