Principal/Director, Product Management

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.

Pay and benefits

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. #LI-IB1

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