Principal/Director, Product Management

Socket.dev; San Francisco (CA); On-site; USD 240,000 - 295,000; Full time

Job summary

Heartflow is seeking a senior product leader to own a portfolio of medical-grade software products. You will shape strategy, define performance targets, and drive regulatory and evidence plans across development, validation, and post-market activities.

You will work closely with engineering, clinical teams, QA/RA, and marketing to ensure a durable place in the care pathway. You will lead integrated care-pathway design, engage with physicians and health-system customers, and communicate portfolio

Qualifications

• Extensive product management experience with FDA-regulated software and at least one product cleared or approved for routine use.
• Deep domain expertise in cardiovascular disease, diagnostic imaging, or multimodal risk assessment.
• Fluency in study design, dataset generalization, and performance validation for medical products.
• Knowledge of design controls, risk management, V&V, and post-market obligations.
• Ability to frame ambiguous problems, size opportunities, and defend recommendations with data.

Responsibilities

• Own multi-year portfolio strategy, decide which problems to solve, and frame partner options.
• Define performance targets, failure modes, and regulatory alignment for claims strategy.
• Map care-pathway end-to-end from referral to reimbursement and design for clinical use.
• Write user needs and system requirements; resolve contested requirements across functions.
• Be the product voice in FDA interactions and maintain audit-ready design history.

Skills

Product management

Regulatory knowledge

Clinical workflow understanding

Data-driven decision making

Influence without authority

UX & usability

Healthcare industry knowledge

Education

BS/MS/PhD in Engineering or Science

Job description

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.

This is a senior individual-contributor role for a product leader who wants to shape how care is delivered. You will own the strategy for a portfolio of medical-grade products — which problems we take on, what performance and outcomes we commit to, and how our products earn a durable place in the care pathway and how our capabilities compose into a product physicians trust, where the portfolio boundaries sit, and how our evidence and regulatory strategy compounds across releases instead of being rebuilt each time. You will be the company’s deepest product-side expert on clinical workflow, validation, and real-world performance, and trusted to make calls that engineering, clinical, and regulatory leadership build on. Success is measured by the quality of decisions the organization makes because of you.

WHAT YOU WILL OWN

• Product strategy: Own the multi-year portfolio strategy. Define which problems are worth solving, sequence the bets, and make documented calls on what we will not pursue. Frame build / partner / acquire options and drive them to a decision.
• Performance and outcomes: Define what “good enough to ship” means before development starts — performance targets, acceptable failure modes, and the intended-use and patient-population boundaries those commitments hold within. Own the claims strategy with Clinical and Regulatory.
• Care-pathway ownership: Map how the product lands in practice end to end — referral, acquisition, interpretation, reporting, follow-up, reimbursement — and design for the people and systems already in that pathway.
• Requirements and design authority: Author user needs and system requirements for the hardest, most ambiguous problems. Where a requirement is contested across functions, you resolve it.
• Regulatory and evidence strategy: Be the product voice in FDA interactions — pre-submission strategy, V&V planning, study and evidence design, post-market surveillance. Keep design history and traceability audit-ready, and treat regulatory constraints as strategy rather than a downstream tax.
• Cross-functional influence: Align engineering, data science, UX, human factors, clinical, QA/RA, marketing, and support around a single product intent — without formal authority over any of them. Build the shared mental model that lets those teams move without waiting on you.
• Customer and market engagement: Maintain direct relationships with physicians, key opinion leaders, advisors, and health-system customers. Represent the product externally, and bring competitive, guideline, and literature insight back into the roadmap.
• Executive communication: Give leadership an honest, quantified view of portfolio risk, performance, and progress — including the inconvenient parts.

WHAT YOU BRING

• Track record: Extensive product management experience with FDA-regulated software, including at least one product taken from concept through clearance or approval and into routine use.
• Domain depth: Real depth in a relevant area — cardiovascular disease, diagnostic imaging and interpretation, multimodal risk assessment, disease pathogenesis, or decision support — enough to hold your own with physicians and in a technical review.
• Validation judgment: Fluency in how medical products are validated: study and dataset design, generalization across patient populations and sites, sensitivity and specificity trade-offs, and the gap between a benchmark result and real-world performance.
• Regulatory fluency: Working command of design controls, risk management, V&V, human factors, and post-market obligations — enough to shape strategy with QA/RA as a peer.
• Strategic and quantitative rigor: Ability to frame ambiguous problems, size opportunities, reason under uncertainty, and defend a recommendation with data and explicit rationale.
• Influence without authority: A history of changing an organization’s direction through clarity and credibility rather than reporting lines.
• Design and usability standard: Strong instincts for visual design, workflow, and usability, and a high bar you hold others to — especially where product output meets interpretation and decision-making.
• Customer orientation: Deep curiosity about how clinicians actually work, and a habit of grounding decisions in observed practice rather than stated preference.
• Adaptability: Comfort where priorities, evidence, and constraints all change.

EDUCATION & EXPERIENCE

• BS, MS, or PhD in Engineering, Science, or a similar technical discipline. An advanced degree or clinical training in a relevant field is a strong plus.
• 15+ years of professional experience, with substantial time in product management for Software as a Medical Device, agile development, and regulated product development.
• Demonstrated experience owning a product area or portfolio at the scale expected of a Principal or Director-level individual contributor.

A note on level: this role is scoped as a range. Principal and Director here are the same individual-contributor track, differentiated by the breadth of portfolio you own and the altitude at which you operate. We calibrate levels during the interview process based on demonstrated scope of influence and depth. A reasonable estimate of the yearly base compensation range is $240,000 to $295,000, cash bonus, and equity.

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.