Senior Director, AI Enabled Digital Products

Edwards Lifesciences Belgium; Irvine (CA); On-site; USD 232,000 - 329,000; Full time

Benefits offered by this job

Edwards Lifesciences benefits

Job summary

Edwards Lifesciences is seeking an experienced Product Leader to define AI-enabled product strategy, ownership of lifecycle, and cross-functional leadership across therapy and workflow opportunities. The role focuses on delivering AI features within a regulated health-tech context and aligning with regulatory and quality teams for submissions.

The ideal candidate has extensive PM experience in medtech, a proven track record with AI-enabled products, and strong analytics to drive adoption and

Qualifications

• Bachelor's degree in a related field with 14 years of product management experience.
• At least 5 years in a regulated software/medtech/health-tech environment.
• Track record shipping AI-enabled products with adoption and lifecycle management.
• Experience shipping software under design controls (ISO 13485 / IEC 62304).
• Direct AI/ML product lifecycle experience (model/versioning/retraining).
• Led products in medtech or FDA-regulated software environments.
• Partnered with regulatory and quality for submissions.

Responsibilities

• Define intended use and claims for AI-enabled features, and own product requirements, roadmap, and lifecycle.
• Define AI-enabled portfolio strategy and sequence investments across therapy/workflow opportunities.
• Build and defend the business case and commercial model for AI-enabled features.
• Validate product-market fit with clinicians, customers, and partners before scaling.
• Own adoption, product analytics, user feedback, and value realization after launch.
• Evaluate ecosystem, licensing, and partnerships to accelerate value.
• Partner with Clinical & Evidence AI on workflow features and shipped product control.
• Define the predetermined change control plan governing product evolution after clearance.

Skills

PM experience

AI-enabled products

Cross-functional leadership

Regulated industry

Product analytics

Education

Bachelor's degree

Tools

Jira

Aha!

Productboard

Job description

USA - California – Irvine

Full time

Req-50782

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 portfoio 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.

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.