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.