Senior Director, AI Enabled Digital Products

Posted 22 Days Ago
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Irvine, CA, USA
In-Office
232K-329K Annually
Senior level
Healthtech • Pharmaceutical
The Role
Leads strategy, requirements, roadmap, lifecycle, commercialization, adoption, and economics for AI-enabled regulated medical products. Defines intended use, claims, change-control plans, and portfolio investments while partnering with clinical, regulatory, quality, commercial, and technical teams. Oversees AI/ML model governance, product-market validation, workflow integration, analytics, evidence generation, and post-market performance for products developed under formal medical-device design controls.
Summary Generated by Built In

At Edwards Lifesciences, the Advanced Innovation & Technology (AI&T) teams harness imagination, courage, and resourcefulness to think beyond what’s currently possible, and create solutions for patients many years into the future.


As part of AI&T, we're building an AI Center of Excellence (COE) focused on applying the power of AI to help patients live longer, healthier lives. As we expand our focus across the structural heart disease journey, AI is creating new opportunities to better understand and improve patient care. Our teams are applying AI to support clinical decision-making, identify patients earlier, develop digital solutions that complement our therapies, and help employees work more efficiently so they can focus on work that matters most. We're building an AI COE that collaborates across our innovation-focused teams throughout our global organization, helping accelerate innovation and build AI capabilities that create lasting impact for patients, clinicians, and employees. Together, we're committed to applying AI responsibly and thoughtfully while keeping patients at the center of everything we do.  


This is a rare opportunity to help define how AI is applied across the structural heart disease journey while shaping the next generation of therapies, digital solutions, and patient experiences. We’ll 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.
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.

Skills Required

  • Bachelor's degree in a related field
  • 14 years of product management experience
  • At least 5 years of experience in a regulated software, medtech, or health-tech environment
  • Track record shipping AI-enabled products with real adoption across discovery, roadmap, lifecycle, and commercial model
  • Experience owning product economics, market adoption, and cross-functional launch outcomes
  • Experience shipping at least one software product under formal design controls, such as ISO 13485 or IEC 62304
  • 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 an FDA-regulated software environment
  • Experience partnering with regulatory and quality functions on submission-track products
  • Master's degree or equivalent
  • 12 years of product management experience with at least 5 years in regulated software, medtech, or health tech
  • AI/ML product lifecycle management experience involving intended use, model versioning, retraining governance, and post-market performance tracking
  • Familiarity with FDA SaMD guidance and the PCCP framework
  • Verification and validation planning and evidence generation for probabilistic AI/ML products
  • Workflow integration, human-factors, and usability experience for physician-facing tools
  • Product requirements and roadmap ownership using Jira, Aha!, Productboard, or equivalent
  • Product analytics and adoption measurement experience using Amplitude, Pendo, or equivalent
  • Executive communication and cross-functional influence across Therapy, R&D, Clinical, Regulatory, Quality, Commercial, and Finance leadership
  • Strong problem-solving, organizational, analytical, critical-thinking, strategic-planning, and cross-functional leadership skills
  • Expert understanding of business strategy, competitive landscape, regulatory environment, and clinical data
  • Experience managing high-stakes technical projects
  • Compliance with company rules, pandemic protocols, and Environmental Health & Safety requirements

Edwards Lifesciences Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Edwards Lifesciences and has not been reviewed or approved by Edwards Lifesciences.

  • Healthcare Strength — Health coverage is considered strong, with multiple plan choices, HSA options, and fertility support, and the company highlights holistic well‑being programs.
  • Retirement Support — A company 401(k) match and well‑regarded retirement offerings add clear long‑term value to total compensation.
  • Equity Value & Accessibility — An Employee Stock Purchase Plan with a discount and look‑back feature makes equity ownership accessible and enhances the total rewards package.

Edwards Lifesciences Insights

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The Company
HQ: Irvine, CA
13,687 Employees
Year Founded: 1958

What We Do

Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more. Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today. Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives. Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life. For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms

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