Director, AI and Digital Health

ECRI•Whitemarsh Township, PA

1d•Remote

About The Position

The Director, AI and Digital Health serves as a key leader in the strategy, development, and execution of technology evaluation initiatives—including AI-enabled solutions, LLMs, Software as a Medical Device (SaMD), connected wearables, and EHR-integrated software—with primary focus on supporting providers and payors. This people-manager role leads multidisciplinary teams and oversees AI and software activities, in partnership with internal stakeholders to ensure we respond to customer needs. The Director partners with clinical, technical, and data subject matter experts to define evaluation objectives, evidence plans, data requirements, and acceptance criteria aligned to real-world clinical workflows, operational needs, and coverage and reimbursement considerations. The Director supports client-facing engagements by translating provider and payor needs into clear evaluation and testing requirements and communicating technical and clinical findings to clinical and industry leaders in a practical, action-oriented manner. The Director oversees evaluation planning and governance, builds scalable processes for test design, validation, and reporting, and drives continuous improvement across automated and manual workflows. As needed, the Director also supports manufacturer-facing collaborations by clarifying evidence expectations and aligning testing approaches to shared quality and regulatory standards. Leveraging expertise in clinical/technical domains and data management, the Director ensures high-quality deliverables that strengthen confidence in AI-enabled, SaMD, wearable, and EHR-integrated solutions. ECRI is a non-profit, independent organization with over 50 years of experience in patient safety and medical technology research. They utilize an unbiased, evidence-based approach to develop guidance and maintain principles of integrity and transparent work. ECRI serves healthcare providers, insurers, government agencies, and medical associations, focusing on Patient Safety, Evidence-Based Medicine, and Technology Decision Support. They are the only organization worldwide to conduct independent medical device evaluations and are designated an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality and a federally certified Patient Safety Organization.

Requirements

10+ years of progressive experience in software/health technology evaluation, quality, validation, and/or test leadership, including work with AI-enabled products and data-driven systems.
3+ years of people management experience, including hiring, coaching, performance management, and leading multidisciplinary teams (e.g. engineering, QA, clinical, data, and security).
Demonstrated experience building and executing SaMD test strategies in regulated or highly governed environments (e.g., design controls, traceability, change control).
Experience building new solutions to meet customer needs.
Client-facing experience translating provider and payor needs into measurable evaluation plans and communicating results, limitations, and risk implications to clinical and industry leaders.
Bachelor’s degree required, preferably in computer or biomedical engineering, information security, or a related clinical science field.
Proficient with Python, LLMs, other AI software and tools.
Proficient with Microsoft Office 365 Suite of products (e.g., Word, Excel, and PowerPoint).
Proficient with Windows-based applications.

Nice To Haves

Experience evaluating connected devices and wearables, including data quality, sensor performance considerations, usability, and end-to-end validation across mobile, cloud, and device components.
Experience with EHR-integrated software testing, including interoperability workflows (e.g., HL7/FHIR concepts), implementation considerations, and validation in real-world clinical settings.
Experience supervising cybersecurity assessment activities for software products (e.g., security requirements, threat modeling partnership, vulnerability management coordination, and audit/client security evidence).
Master’s or doctoral degree preferred, preferably in computer or biomedical engineering, information security, or a related clinical or data science field.
CompTIA Security+ (or equivalent) and/or cloud security training relevant to the hosted environment (e.g., Azure/AWS/GCP security).
IAPP CIPP/US (or comparable privacy credential); HCISPP is a plus.
RAPS RAC (US or Global) and/or ASQ CQA/CQE (or equivalent quality systems credential).

Responsibilities

Lead the execution of evaluation and testing programs across AI-enabled solutions, SaMD, connected wearables, and EHR-integrated software to support provider and payor decision-making.
Lead client-facing requirements discovery and technical communication, presenting evaluation results and implications to clinical and industry leaders.
Define evaluation objectives, data requirements, and acceptance criteria aligned to clinical workflows, operational constraints, and coverage/reimbursement considerations.
Translate safety, regulatory, and cybersecurity expectations into testable requirements; ensure appropriate documentation, traceability, and risk management for software, data, and integrations.
Design, oversee, and continuously improve validation and verification approaches (manual and automated), including test design, protocols, and reporting templates.
Partner with product and engineering teams throughout the feature and product lifecycle to build quality in, review risk assessments, support testing design, and drive decisions on readiness and release.
Develop and maintain SOPs, training materials, and scalable processes to enable consistent implementation and continuous improvement across evaluation and testing teams.
Supervise cybersecurity evaluation and testing activities (e.g., security requirements, threat modeling support, vulnerability management coordination, and security evidence for clients) in collaboration with internal security partners.
Other duties, as assigned.
Meet or exceed annual budget goals.
Meet or exceed annual organizational, divisional, departmental, and/or individual goals.
Establish and maintain exceptional and professional client relationships, both with existing and new clients.
Maintain division excellence with regard to work quality and business/personnel management.

Benefits

Medical insurance
Dental insurance
Vision insurance
Life insurance
Accidental death and dismemberment insurance
Disability coverage
Employer-matching 403(b) Retirement Savings Plan
Paid time off
Holiday pay
Paid leave for parents
Tuition assistance
Employee assistance program
Access to LinkedIn Learning
Voluntary benefit programs (e.g. accident insurance, identify theft insurance, flexible spending accounts)
16 hours annually of paid time to volunteer at preapproved ECRI Cares charities during normal business hours
Health and welfare benefits