Senior Director, AI Enabled Digital Products
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What you'll do
- 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 they're looking for
- 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
Nice to have
- 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
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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.
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.
Company
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