Senior Director, AI Enabled Digital Products

Edwards Lifesciences Gruppe; Alton (IL); On-site; USD 210,000 - 320,000; Full time

Job summary

Edwards Lifesciences Gruppe is seeking an experienced AI/Tech Product Manager to own AI-enabled product strategy for structural heart solutions. You will define intended use, roadmap, and lifecycle management for regulated software in collaboration with clinical teams and commercial partners.

The role requires leadership across Therapy, R&D, Regulatory, and Quality segments, with intent to deliver robust business cases, market adoption, and post-launch value realization in a regulated

Qualifications

• Bachelor's degree required; background in medtech or health-tech preferred.
• Experience shipping AI-enabled products through full lifecycle, including model updates.
• Proven ability to own product economics, market adoption, and cross-functional launches.

Responsibilities

• Define intended use and claims for AI-enabled features and own product requirements, roadmap and lifecycle.
• Build and defend the business case and commercial model for AI-enabled therapy features.
• Partner with regulatory and quality functions on SaMD submissions and post-market activities.

Skills

Product management

AI/ML product lifecycle

Cross-functional leadership

Regulatory software

Education

Bachelor's Degree

Master's Degree

Tools

Jira

Aha!

Productboard

Job description

Innovation starts from the heart. Our Advanced Innovation & Technology (AI&T) teams harness imagination, courage, and resourcefulness to think beyond what is currently possible and create solutions for patients many years into the future. If you are an early-stage innovator, the Edwards AI&T team is the place for you to take the next step in your career. We will give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology .How you will make an impact:Define intended use and claims for AI-enabled features, and own the related product requirements, roadmap, and lifecycleDefine the AI-enabled product portfolio strategy and sequence investments across therapy and workflow opportunitiesBuild and defend the business case and commercial model for AI-enabled therapy featuresValidate product-market fit with clinicians, customers, therapy leaders, and commercial partners before scaling investmentOwn adoption, product analytics, user feedback, and value realization after launchEvaluate ecosystem, licensing, and partnership options when they accelerate differentiated product valuePartner with Clinical & Evidence AI on procedural-workflow features, owning the workflow as a shipped product while clinical teams own the correctness of the guidance itselfDefine the predetermined change control plan that governs how the product can evolve after clearanceWhat 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 environmentA track record shipping AI-enabled products that achieved real adoption, spanning discovery, roadmap, lifecycle, and commercial modelDemonstrated ownership of product economics, market adoption, and cross-functional launch outcomes, not only roadmap deliveryExperience 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 launchPrior product leadership in medtech, health tech, or another FDA-regulated software environmentExperience 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 environmentAI/ML product lifecycle management specifically: intended use definition, model versioning and retraining governance, and post-market performance tracking, distinct from general software product lifecycle workWorking familiarity with FDA Software as a Medical Device (SaMD) guidance and the predetermined change control plan (PCCP) frameworkVerification 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 deterministicWorkflow 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 toolProduct requirements definition and roadmap ownership for a regulated, evidence-driven product, using tools such as Jira, Aha!, or ProductboardProduct analytics and adoption measurement (Amplitude, Pendo, or equivalent)Executive communication, portfolio judgment, and influence across Therapy, R&D, Clinical, Regulatory, Quality, Commercial, and Finance leadershipExcellent problem-solving, organizational, analytical , and critical - thinking skills , including sound discretion and judgment in decision - makingExpert understanding of business strategy, competitive landscape, regulatory environment, and clinical data while looking beyond existing methodologies and own discipline to define and resolve complex problemsStrong experience in cross-functional team leadership, strategic planning, and managing high-stakes technical projectsAdhere 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 controlAligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.For California, the base pay range for this position is $232,000 to $329,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.