Senior Product Manager, SaMD Diagnostics
Core
Define requirements and manage the development lifecycle of SaMD iOS applications for early Alzheimer's disease diagnosis and patient notification of FDA-approved drugs and clinical trials.
Role type
Senior Product Manager (SaMD Diagnostics)
Builds
Gen 0 to Gen 2.0+ SaMD applications for iOS, Android, MacOS, and Windows
Domain
Healthcare / Neurodegenerative disease diagnostics / Software as Medical Device
Deliverable
production ML models | product features
Required skills
SaMD product management, iOS/Android/MacOS/Windows development lifecycle, AI-assisted app prototyping (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 Project, MBA, marketing/business development
Technologies
iOS, Android, MacOS, Windows, Claude Code, supervised machine learning algorithms
Responsibilities
Establish and revise comprehensive requirements for novel SaMD applications, develop functional Gen 0 app using AI tools, serve as primary contact for ML model integration into Gen 1.0 apps, lead development and QA testing for Gen 2.0 and future generations
Seniority
Senior, hands-on IC
