Drive product realization process from planning through verification/validation in a regulated SaMD environment
Lead cross-functional collaboration across product, engineering, AI, regulatory, and quality teams
Lead risk analysis per ISO 14971 and IEC 62304
Trace requirements to architecture, design, and verification/validation test cases for compliance
Coordinate with AI scientists, engineers, and product managers to prepare regulatory documentation
Manage agile ceremonies, sprint planning, and release readiness

🎯 Requirements

5+ years of technical program management experience
Experience in a highly regulated medical device environment with ISO 13485, ISO 14971, IEC 62304, AAMI TIR 45
BS in Engineering preferred or other relevant field
Certified Scrum Master with experience facilitating agile processes
Excellent verbal and written communication skills
Demonstrated experience maintaining product documentation and versioning within a Quality Management System

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