Senior Director, AI-Enabled MedTech Solutions

Edwards Lifesciences; Alton (TX); On-site; USD 232,000 - 329,000; Full time

Job summary

Edwards Lifesciences seeks a seasoned product leader for AI-enabled therapies within its Advanced Innovation & Technology team. You will own the product lifecycle from discovery through launch, defining use, roadmap, and commercial models for AI features in regulated medical software.

You will partner with Regulatory, Quality, Clinical and R&D teams to ensure FDA and ISO compliance, manage model versioning, and drive adoption with clinicians and partners.

Qualifications

• Bachelor's or higher in a related field with extensive PM experience in regulated software/medtech.
• Proven track record shipping AI-enabled products with lifecycle ownership and commercial models.
• Experience in design controls and FDA/regulatory environment for software products.

Responsibilities

• Define intended use, claims, and lifecycle for AI-enabled features.
• Shape AI-enabled portfolio strategy and investment sequencing.
• Build and defend business cases and commercial models for AI features.
• Validate product-market fit with clinicians and partners.
• Own adoption analytics, feedback, and post-launch value realization.
• Evaluate ecosystem and partnerships to accelerate product value.
• Partner with Regulatory/Quality on submissions and PCCP governance.
• Define change control plans for post-clearance evolution.

Skills

Product management

Regulated software experience

AI/ML product lifecycle

Cross-functional leadership

Executive communication

Analytical thinking

Problem-solving

Strategic planning

Education

Bachelor's Degree

Master's Degree

Tools

Jira

Aha!

Productboard

Amplitude

Pendo

Job description

Edwards Lifesciences seeks a seasoned product leader for AI-enabled therapies within its Advanced Innovation & Technology team. You will own the product lifecycle from discovery through launch, defining use, roadmap, and commercial models for AI features in regulated medical software.

You will partner with Regulatory, Quality, Clinical and R&D teams to ensure FDA and ISO compliance, manage model versioning, and drive adoption with clinicians and partners.