The Director of Patient Medical Devices will coordinate the cross-functional development, clinical validation, regulatory readiness, product release, lifecycle management, and continued development of a patient-facing digital medical-device portfolio. This position has a dual reporting relationship to the VP, Clinical Product and VP, Cloud Platform. Working across a cross-functional product lifecycle development team, the Director will serve as the central point of integration for regulated products developed within a broader Intelligent Therapeutic Platform. The portfolio will include LLM-based agentic AI medical devices, digital therapeutics, Software as a Medical Device (SaMD) and companion digital therapeutic products, and other patient-facing software supporting chronic disease, medication therapy, recovery, and transitions of care. The position will coordinate the application of established platform technologies to disease-specific and medication-specific medical devices. It will not determine the company’s foundational technology strategy or hold responsibility for product commercialization. The Director will ensure that technical development, clinical requirements, regulatory activities, quality controls, and ongoing product evolution are coordinated as an integrated medical-device program. Because LLM-based agents represent a rapidly evolving medical-device category, the Director will work with Quality, Regulatory Affairs, Medical, Engineering, and Clinical teams to operationalize new approaches to regulatory quality control, validation, controlled product change, and post-release performance monitoring. The role is focused on medical devices whose primary intended users are patients or caregivers. Independent provider-facing clinical AI products are outside the position’s primary scope. Success in this position will be measured by: effective cross-functional coordination advancement of patient medical devices through agreed technical, clinical, quality, and regulatory milestones implementation of defensible quality controls for LLM-based agents timely and controlled product updates completely traceable and audit-ready documentation clinically appropriate agent behavior effective post-market monitoring safe, reliable, and continued evolution of patient medical devices throughout their product lifecycles Required Qualifications Three or more years’ experience in medical devices, digital health, Software as a Medical Device (SaMD), digital therapeutics, AI-enabled products, pharmaceutical digital products, or a related regulated field. Demonstrated experience coordinating complex, cross-functional medical-device or regulated software-development programs. Experience supporting medical device products through design, clinical validation, regulatory submission or authorization, controlled release, post-market monitoring, and continued product development. Strong working knowledge of medical-device quality systems, design controls, risk management, software lifecycle processes, verification and validation, clinical evidence, human factors, cybersecurity, configuration management, and post-market surveillance. Technical fluency in LLMs, agentic architectures, retrieval-augmented generation, model evaluation, cloud platforms, APIs, connected devices, mobile applications, and healthcare data. Experience coordinating Product, Engineering, Medical, Quality, Regulatory Affairs, Clinical, Security, Legal, and external partner teams. Strong understanding of chronic‑disease management, medication therapy, digital therapeutics, patient engagement, home‑based care, or transitions of care. Advanced degree in medicine, nursing, pharmacy, biomedical engineering, computer science, human factors, public health, behavioral science, or a related field, or equivalent professional experience. #J-18808-Ljbffr
Director, Patient Medical Devices • Indiana, PA, United States
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