• Define intended use and claims for AI-enabled features, and own the related product requirements, roadmap, and lifecycle

• Define the AI-enabled product portfolio strategy and sequence investments across therapy and workflow opportunities

• Build and defend the business case and commercial model for AI-enabled therapy features

• Validate product-market fit with clinicians, customers, therapy leaders, and commercial partners before scaling investment

• Own adoption, product analytics, user feedback, and value realization after launch

• Evaluate ecosystem, licensing, and partnership options when they accelerate differentiated product value

• Partner with Clinical & Evidence AI on procedural-workflow features, owning the workflow as a shipped product while clinical teams own the correctness of the guidance itself

• Define the predetermined change control plan that governs how the product can evolve after clearance

What you'll need (Required):

• Bachelor's Degree in a related field plus 14 years of product management experience, with at least 5 years in a regulated software, medtech, or health-tech environment

• A track record shipping AI-enabled products that achieved real adoption, spanning discovery, roadmap, lifecycle, and commercial model

• Demonstrated ownership of product economics, market adoption, and cross-functional launch outcomes, not only roadmap delivery

• Experience shipping at least one software product under formal design controls (ISO 13485, IEC 62304, or equivalent)

• Direct experience managing an AI/ML product through its full lifecycle, including model versioning, retraining cadence, and performance drift after launch

• Prior product leadership in medtech, health tech, or another FDA-regulated software environment

• Experience partnering with regulatory and quality functions on submission-track products

What else we look for (Preferred):

• Master's Degree or equivalent plus 12 years of product management experience, with at least 5 years in a regulated software, medtech, or health-tech environment

• AI/ML product lifecycle management specifically: intended use definition, model versioning and retraining governance, and post-market performance tracking, distinct from general software product lifecycle work

• Working familiarity with FDA Software as a Medical Device (SaMD) guidance and the predetermined change control plan (PCCP) framework

• Verification and validation (V&V) planning and evidence generation for AI/ML-based products, including test protocol design for a model whose behavior is probabilistic rather than deterministic

• Workflow integration design: embedding an AI feature into an existing clinical or procedural workflow without disrupting it, including human-factors and usability considerations for a physician-facing tool

• Product requirements definition and roadmap ownership for a regulated, evidence-driven product, using tools such as Jira, Aha!, or Productboard

• Product analytics and adoption measurement (Amplitude, Pendo, or equivalent)

• Executive communication, portfolio judgment, and influence across Therapy, R&D, Clinical, Regulatory, Quality, Commercial, and Finance leadership

• Excellent problem-solving, organizational, analytical, and critical-thinking skills, including sound discretion and judgment in decision-making

• Expert understanding of business strategy, competitive landscape, regulatory environment, and clinical data while looking beyond existing methodologies and own discipline to define and resolve complex problems

• Strong experience in cross-functional team leadership, strategic planning, and managing high-stakes technical projects

• Adhere to all company rules and requirements, including pandemic protocols and Environmental Health & Safety rules; take adequate control measures to prevent injuries to oneself and others, protect the environment, and prevent pollution within the span of influence and control