Senior Product Manager, SaMD Diagnostics
Core
Develop and manage requirements for novel SaMD (Software as Medical Device) iOS applications diagnosing Alzheimer's disease and notifying patients of FDA-approved drugs and clinical trials.
Role type
Senior Product Manager (SaMD Diagnostics)
Builds
Gen 0–2.0 SaMD apps for iOS, Android, MacOS, and Windows devices
Domain
Healthcare / Neurodegenerative disease diagnostics / Software as Medical Device
Deliverable
production ML models
Required skills
SaMD product management, iOS/Android/MacOS/Windows development, AI tooling (Claude Code), cross-functional team leadership, FDA regulatory knowledge (IEC 62304, QMSR, ISO 13485)
Preferred skills
Overseas development/QA team management, early-stage startup experience, MS in Computer Science, MBA
Technologies
iOS, Android, MacOS, Windows, Claude Code, supervised machine learning
Responsibilities
Establish and revise requirements for SaMD applications, develop functional Gen 0 app using AI tools, act as primary contact for ML model integration and future app generations, coordinate with engineering and QA teams
Seniority
Senior, hands-on IC
