Senior Director, AI Enabled Digital Products
About The Position
As part of Edwards Lifesciences’ Advanced Innovation & Technology teams, the Senior Director, AI Enabled Digital Products will help define how AI is applied across the structural heart disease journey. The role is part of an AI Center of Excellence focused on using AI to improve patient care, support clinical decision-making, identify patients earlier, develop digital solutions that complement therapies, and improve employee efficiency. The position shapes AI-enabled therapies, digital solutions, and patient experiences, with a commitment to responsible, thoughtful AI centered on patients. The role defines intended use and claims for AI-enabled features and owns associated product requirements, roadmaps, and lifecycle. It sets portfolio strategy and investment sequencing, develops business cases and commercial models, validates product-market fit, and owns adoption, analytics, user feedback, and value realization after launch. The Senior Director evaluates ecosystem, licensing, and partnership options and partners with Clinical & Evidence AI on procedural-workflow features. For those features, this role owns the shipped workflow product while clinical teams own the correctness of the guidance. It also defines the predetermined change control plan governing product evolution after clearance.
Requirements
- Bachelor's degree in a related field plus 14 years of product management experience, including at least 5 years in a regulated software, medtech, or health-tech environment.
- 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, such as ISO 13485, IEC 62304, or equivalent.
- Direct experience managing an AI/ML product through its full lifecycle, including model versioning, retraining cadence, and post-launch performance drift.
- Prior product leadership in medtech, health tech, or another FDA-regulated software environment.
- Experience partnering with regulatory and quality functions on submission-track products.
Nice To Haves
- Master's degree or equivalent plus 12 years of product management experience, including at least 5 years in a regulated software, medtech, or health-tech environment.
- AI/ML product lifecycle management, including 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 planning and evidence generation for AI/ML-based products, including test protocol design for probabilistic model behavior.
- Workflow integration design that embeds an AI feature into an existing clinical or procedural workflow without disrupting it, including human-factors and usability considerations for physician-facing tools.
- Product requirements definition and roadmap ownership for regulated, evidence-driven products, using tools such as Jira, Aha!, or Productboard.
- Product analytics and adoption measurement using 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, with the ability to look beyond existing methodologies and one's own discipline to define and resolve complex problems.
- Strong experience in cross-functional team leadership, strategic planning, and managing high-stakes technical projects.
Responsibilities
- Define intended use and claims for AI-enabled features and own 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.
- Adhere to company rules and requirements, including pandemic protocols and Environmental Health & Safety rules, and take adequate control measures to prevent injuries, protect the environment, and prevent pollution within the span of influence and control.
Benefits
- Competitive salaries
- Performance-based incentives
- A wide variety of benefits programs to address the diverse individual needs of employees and their families
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What This Job Offers
Job Type
Full-time
Career Level
Senior
