Guides software development teams in the creation and maintenance of Design and Development Files (DDFs), including software development plans, verification and validation plans, software requirements specifications, architecture and design documents, design and code reviews, Risk Management Files (RMF), test protocols and reports, and traceability matrices. Experience with AI/ML-enabled medical device products, including familiarity with FDA AI/ML SaMD guidance, predetermined change control plans (PCCP), and post-market performance monitoring for generative AI applications; experience using generative AI tools (e.g., Gemini, Claude, ChatGPT) to enhance quality and compliance workflows is a plus.