Lead the technical architecture and evolution of the ReActiv8 implantable medical device system across embedded firmware, mobile, web, and cloud infrastructure. Define software architecture strategies, translate clinical and regulatory requirements into compliant designs per IEC 62304 and FDA expectations, and establish coding standards and design principles for the engineering team.… Drive architecture reviews, design control activities, hazard analysis, and FDA regulatory submissions while mentoring software engineers across firmware, application, and cloud domains. Maintain development tools and practices including Azure DevOps, Git, and AI-assisted workflows in a regulated medical device context.
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