Software Development Manager - Merge Hemo
Core
Lead software engineering for Merge Hemo, a mission-critical, FDA-regulated medical device software platform used in cath labs and hospital environments.
Role type
Senior Engineering Manager (Medical Device Software)
Builds
Medical device software solutions for hemodynamic monitoring and cath lab environments
Domain
Healthcare / Medical Device Software / Regulated SDLC
Deliverable
production ML models | product features
Required skills
People leadership, Agile/Scrum delivery, Regulated SDLC execution, Risk management, V&V, Architecture guidance, Generative AI tooling
Preferred skills
Clinical systems experience, HL7 integrations, FDA submission support, AI-assisted development pipelines
Technologies
Generative AI tools (Copilot, Claude), End-to-end Agentic pipelines
Responsibilities
Lead and manage a team of software engineers, Own Agile delivery execution, Drive end-to-end SDLC in regulated environment, Provide technical leadership across design and validation, Partner with software architects, Ensure compliance with FDA regulations, Recruit and mentor engineers, Champion responsible use of Generative AI tools
Seniority
Senior, hands-on IC with people management