WHY CHOOSE ECRI? ECRI is an inspiring place to work. We share a common mission to help healthcare organizations make smart, compassionate, and ethical decisions for patients. Consider these additional benefits of joining the ECRI team: • Industry leadership:We have a long history and proven reputation in patient safety and medical technology research. • On-the-job-learning:You will have the opportunity to work with specialists across medical science, patient care, healthcare management, and technology. • Comprehensive healthcare benefits:We offer medical, dental, vision, life insurance, accidental death and dismemberment, and disability coverage. • Retirement Savings:Our employees can participate in an employer-matching 403(b) Retirement Savings Plan. • Additional benefits:ECRI offers additional benefits to our employees, including paid time off and holiday pay, paid leave for parents, tuition assistance, employee assistance program, access to LinkedIn Learning, and other voluntary benefit programs (e.g. accident insurance, identify theft insurance, flexible spending accounts). • Volunteer Program:ECRI Cares, our employee volunteer program, provides a framework for us to work together and make a difference in the lives of others. All employees are provided 16 hours annually of paid time to volunteer at preapproved ECRI Cares charities during normal business hours. ABOUT ECRI At ECRI, our passion for safe, effective, and efficient care is ingrained into the fabric of who we are and why we are here. For more than 50 years, the people of ECRI have been unyielding in their work to protect patients from unsafe and ineffective medical technologies and practices. Now, with the acquisition of the Institute for Safe Medication Practices (ISMP), we have created one of the largest healthcare quality and safety entities in the world. As a non-profit, independent organization, we utilize an unbiased, evidence-based approach to develop guidance, and maintain our principles of integrity and transparent work. Our ethical standards have led us to adopt the industry's strictest conflict-of-interest policies, and they are why tens of thousands of healthcare leaders worldwide rely on ECRI to guide their clinical, operational, and strategic decisions across all sites of care. The Most Trusted Voice in Healthcare ECRI is proud to serve the healthcare industry, from providers and insurers to government agencies, and medical associations. Our areas of focus include: • Patient Safety: empowering leaders to eliminate patient harm through the dissemination of best practices, guidance, benchmarking, and recommendations. • Evidence-Based Medicine: providing clinical evidence to inform and support decisions on the effectiveness of medical technologies, procedures, genetic tests, and clinical practice guidelines. • Technology Decision Support: arming hospital systems with unbiased insights, so they can optimize their supply chain. ECRI is the only organization worldwide to conduct independent medical device evaluations, with labs located in North America and Asia Pacific. ECRI is designated an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality and a federally certified Patient Safety Organization by the U.S. Department of Health and Human Services. At ECRI, our passion for the truth drives us to go further and dig deeper in our pursuit to advance effective, evidence-based healthcare globally. The success of our organization relies on the kind of creative thinking that can only result from a diverse team of individuals. ECRI is proud to be an employer of choice with an inclusive environment for all employees. As part of this goal and in compliance with various laws and regulations, ECRI provides reasonable accommodation to applicants and employees. It's what makes ECRI unique, and why we are the most trusted voice in healthcare. POSITION SUMMARY 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. ESSENTIAL FUNCTIONS Reasonable Accommodation Statement: To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions. Essential Functions: 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. Additional Responsibilities: Other duties, as assigned. Accountability Metrics: 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. POSITION QUALIFICATIONS Experience: 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. Preferred: experience evaluating connected devices and wearables, including data quality, sensor performance considerations, usability, and end-to-end validation across mobile, cloud, and device components. Preferred: experience with EHR-integrated software testing, including interoperability workflows (e.g., HL7/FHIR concepts), implementation considerations, and validation in real-world clinical settings. Preferred: experience supervising cybersecurity assessment activities for software products (e.g., security requirements, threat modeling partnership, vulnerability management coordination, and audit/client security evidence). Client-facing experience translating provider and payor needs into measurable evaluation plans and communicating results, limitations, and risk implications to clinical and industry leaders. Education: Bachelor's degree required, preferably in computer or biomedical engineering, information security, or a related clinical science field. Master's or doctoral degree preferred, preferably in computer or biomedical engineering, information security, or a related clinical or data science field. Computer Skills: 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 Certifications and Licenses: Required: None. Preferred (Security fundamentals/operations): CompTIA Security+ (or equivalent) and/or cloud security training relevant to the hosted environment (e.g., Azure/AWS/GCP security). Preferred (Privacy/healthcare data): IAPP CIPP/US (or comparable privacy credential); HCISPP is a plus. Preferred (Medical device/SaMD quality & regulatory): RAPS RAC (US or Global) and/or ASQ CQA/CQE (or equivalent quality systems credential). POSITION COMPENSATION The salary range for new employees in this position is $147,054 - $183,817 based on background, experience, and skills. In addition, new employees in this position are eligible for all of our benefit offerings, including, but not limited to, health and welfare benefits, 403(B) retirement savings, and paid time off (PTO). PHYSICAL DEMANDS This position operates in a remote environment and requires the individual to remain in a stationary position, whether sitting or standing, before a desk or other fixed workspace, most of their workday. In addition, this position requires the individual to occasionally move about their workspace to access and inspect work-related materials, such as file cabinets with physical files and standard office equipment. This position requires the ability to operate standard office equipment, including, but not limited to, a laptop, keyboard, mouse, webcam, and phone, as well as effectively communicate information and ideas to a wide variety of audiences in written and oral form. ADA STATEMENT ECRI is committed to providing equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, genetics, sexual orientation, gender identity, or veteran status. We value diversity and believe that a diverse workforce enhances our ability to succeed. ECRI complies with applicable federal, state, and local laws governing nondiscrimination in employment and prohibits any form of discrimination or harassment based on these protected characteristics. EEO STATEMENT ECRI is committed to providing equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, genetics, sexual orientation, gender identity, or veteran status. We value diversity and believe that a diverse workforce enhances our ability to succeed. ECRI complies with applicable federal, state, and local laws governing nondiscrimination in employment and prohibits any form of discrimination or harassment based on these protected characteristics. #LI-Remote