Senior Director, AI Enabled Digital Products

Edwards Lifesciences; Irvine, Northern (CA, KY); Hybrid; USD 232,000 - 329,000; Full time

Benefits offered by this job

competitive salaries

performance-based incentives

wide variety of benefits programs

Job summary

Edwards Lifesciences in Irvine, CA is seeking an experienced AI/ML Product Manager to lead regulatory-compliant product initiatives in structural heart technology. You will own AI-enabled features, define the portfolio strategy, and build the business case to drive adoption and post-launch value realization.

The role requires a Bachelor's degree with 14+ years in product management, including at least 5 years in regulated software/medtech.

Qualifications

• Bachelor's degree in a related field with significant PM experience in regulated environments.
• Track record shipping AI-enabled products with real adoption and lifecycle management.
• Experience with design controls (ISO 13485, IEC 62304) or equivalent.
• Direct experience managing AI/ML products through full lifecycle including model versioning and retraining.

Responsibilities

• Define AI-enabled product portfolio strategy and investment sequencing.
• Own business case and commercial model for AI-enabled therapy features.
• Validate product-market fit with clinicians and partners before scaling.
• Own adoption, analytics, and value realization after launch.

Skills

Product management

AI/ML product lifecycle

Cross-functional leadership

Regulated software experience

Regulatory awareness

Education

Bachelor's Degree

Master's Degree (preferred)

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 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

Aligning 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.

• competitive salaries
• performance-based incentives
• a wide variety of benefits programs

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.