Executive Director – AI and Digital Health Assurance

🔥 0 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $180k - $225k / year

⏰ Full Time

🔴 Lead

🤖 Artificial Intelligence

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ECRI

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1968

💼 Consulting

📦 Logistics

🏥 Healthcare

Consulting • Logistics • Healthcare

ECRI is a nonprofit healthcare safety organization that provides independent evidence-based evaluations, medical device testing, patient safety advisory services, supply chain intelligence, education, and consulting to healthcare providers, payers, manufacturers, and government. With more than five decades of experience, a nationwide dataset of safety events, and a team of experts, ECRI operates as the only organization designated as both an Evidence-based Practice Center and a Patient Safety Organization and the sole independent medical device testing laboratory, helping organizations reduce preventable harm and improve care quality and value.

📋 Description

• Design and launch ECRI's AI assurance offering from concept to an operating, revenue-generating practice • Define the service architecture, methodology, delivery model, and commercial structure • Own bookings, revenue, margin, and retention for the practice • Partner with sales, marketing, and product strategy to build pipeline and lead client pursuits as senior technical authority • Productize recurring practice elements into scalable products and tools • Establish evaluation strategy covering evidence requirements, test design, datasets, data provenance, subgroup fairness, acceptance criteria, and reporting standards • Track foundation model releases, agentic architectures, clinical AI platforms, healthcare AI adoption, and shadow AI use • Direct design and operation of a secure AI testing sandbox for accuracy, robustness, failure modes, non-determinism, confabulation, and prompt sensitivity • Build AI safety event surveillance intake, taxonomy, and analytics capabilities • Lead root cause investigations of suspected AI-related harm and translate findings into corrective action • Design post-deployment monitoring for model drift, data shift, vendor-update degradation, and clinical-benefit erosion • Advise boards, executives, AI governance committees, and vendor executives on AI assurance findings and regulatory expectations • Track FDA, Joint Commission, CHAI, NIST AI RMF, ISO/IEC 42001, ISO 14971, and IEC 62304 requirements • Direct security and threat evaluation, including prompt injection, adversarial manipulation, agentic attack surfaces, supply-chain exposure, shadow AI, and access control • Recruit, develop, and lead a multidisciplinary clinical, data science, engineering, human factors, and cybersecurity team • Establish standard operating procedures, training, quality control, and peer review • Protect ECRI's independence through conflict-of-interest and firewall protocols • Represent ECRI in external standards, policy, and consensus forums • Contribute AI-related content to ECRI publications and thought leadership • Advise ECRI's internal AI program on safe and defensible AI use • Meet agreed offering-launch, commercial, evaluation, safety-corpus, client, team, independence, and organizational goals

🎯 Requirements

• 10+ years of progressive experience in healthcare technology evaluation, clinical software quality and validation, medical device or health IT safety, or a closely related discipline • 3+ years of hands-on leadership or delivery experience involving AI- or ML-enabled systems, including generative AI, agentic systems, or large language model applications • 5+ years leading teams, with success building a function, practice, or program from an early or undefined state • Experience shipping an AI-enabled product or feature into production and operating it post-launch, with accountability for performance, user adoption, and iteration • Deep and current command of AI and machine learning as applied in healthcare • Experience designing and executing validation or evaluation strategies for clinical software in regulated or highly governed environments, including design controls, traceability, change control, and risk management • Experience building or operating infrastructure to exercise and test AI systems in a controlled sandbox, including benchmark and adversarial test sets • Proven client-facing experience translating provider, payer, and vendor needs into measurable evaluation plans and communicating technical and clinical findings • Demonstrated commercial contribution, including shaping offerings, scoping and pricing engagements, supporting pursuits, and growing client relationships • Established credibility with senior healthcare and industry leaders through publication, standards or consensus participation, or speaking at recognized venues • Bachelor's degree required in computer science, biomedical or software engineering, data science, information security, health informatics, or a related technical or scientific field • An equivalent combination of education and directly relevant experience will be considered • Advanced, current, hands-on fluency across multiple foundation model families, agent and orchestration frameworks, and model/prompt evaluation and observability tooling • Working knowledge of OWASP Top 10 for LLM Applications and MITRE ATLAS • Working familiarity with Python, R, or SQL • Proficient with Microsoft 365 and standard collaboration tools • Travel percentage: 25% • Preferred: patient safety event analysis and root cause methodology; Patient Safety Organization, risk management, or quality and safety experience • Preferred: connected and wearable device validation, EHR-integrated clinical decision support and workflow integration, or health AI assurance frameworks • Preferred certifications: ISO/IEC 42001 lead implementer or auditor, RAPS RAC, ASQ CQA/CQE, or CPPS

🏖️ Benefits

• Comprehensive healthcare coverage: Medical, dental, vision, life insurance, disability coverage, critical illness insurance, and more • Employer-matching Retirement Savings Plan / 403(B) retirement savings • Culture of Belonging employee groups • 16 paid hours annually through ECRI Cares to volunteer with preapproved charities • Paid time off (PTO)