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About the Role
This senior individual-contributor role focuses on leading product strategy for a portfolio of medical-grade products, defining problem areas, performance targets, and market integration. You will be the primary product expert on clinical workflow, validation, and real-world performance, influencing key decisions across engineering, clinical, and regulatory teams.
Responsibilities
- Own the multi-year portfolio strategy, defining problems to solve and sequencing bets.
- Frame and drive build/partner/acquire options for product development.
- Define 'good enough to ship' criteria, including performance targets and acceptable failure modes.
- Own the claims strategy in collaboration with Clinical and Regulatory teams.
- Map and design product integration into the end-to-end clinical pathway.
- Author user needs and system requirements for complex and ambiguous problems.
- Resolve requirement conflicts across different functions.
- Act as the product representative in FDA interactions, including pre-submission strategy and V&V planning.
- Maintain design history and traceability for audit readiness.
- Treat regulatory constraints as strategic opportunities.
- Align engineering, data science, UX, human factors, clinical, QA/RA, marketing, and support around product intent without formal authority.
- Build a shared understanding to enable teams to operate autonomously.
- Maintain direct relationships with physicians, key opinion leaders, advisors, and health-system customers.
- Represent the product externally and incorporate market insights into the roadmap.
- Provide leadership with honest, quantified assessments of portfolio risk, performance, and progress.
Requirements
- Extensive product management experience with FDA-regulated software.
- At least one product taken from concept through clearance or approval and into routine use.
- Real depth in a relevant area such as cardiovascular disease, diagnostic imaging and interpretation, multimodal risk assessment, disease pathogenesis, or decision support.
- Fluency in medical product validation, including study and dataset design, generalization across populations and sites, and sensitivity/specificity trade-offs.
- Working command of design controls, risk management, V&V, human factors, and post-market obligations.
- Ability to frame ambiguous problems, size opportunities, reason under uncertainty, and defend recommendations with data.
- History of influencing organizational direction through clarity and credibility.
- Strong instincts for visual design, workflow, and usability.
- Deep curiosity about clinician workflows and a habit of grounding decisions in observed practice.
- Comfort with changing priorities, evidence, and constraints.
Skills
- Product Strategy
- Product Management
- FDA-regulated Software
- Clinical Workflow
- Validation
- Real-world Performance
- Design Controls
- Risk Management
- V&V
- Human Factors
- Post-market Obligations
- Strategic Rigor
- Quantitative Rigor
- Influence without Authority
- Design
- Usability
- Customer Orientation
- Adaptability
Location
- US
- UK
- Europe
- Japan
- Canada
Work Type
- Full-time
Experience Level
- 15+ years of professional experience
- Substantial time in product management for Software as a Medical Device
- Agile development experience
- Regulated product development experience
- Demonstrated experience owning a product area or portfolio at the scale expected of a Principal or Director-level individual contributor
Education Level
- BS, MS, or PhD in Engineering, Science, or a similar technical discipline
- Advanced degree or clinical training in a relevant field is a strong plus
Salary/Compensations
- $240,000 to $295,000
- cash bonus
- equity
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 is an AI-driven, non-invasive cardiac test called the Heartflow FFRCT Analysis.
- Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway.
- Heartflow is a publicly traded company (HTFL).
- The company has received international recognition for exceptional strides in healthcare innovation.
- The product is supported by medical societies around the world and cleared for use in the US, UK, Europe, Japan and Canada.
- The product has been used for more than 750,000 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.