Software CoE Manager
Core
Leads the Software Center of Excellence (COE) to drive engineering excellence, govern software requirements and system design, and ensure regulatory compliance and cybersecurity for medical device software.
Role type
Manager, Software Center of Excellence (COE)
Builds
Robust, compliant, and AI-augmented software solutions for medical devices
Domain
Medical Devices / Health Technology / Software Engineering
Deliverable
production ML models | product features | infrastructure
Required skills
Software Requirement & System Design, Regulatory Compliance, Cybersecurity, CAPA management, DFMEA, Risk Management, People Management, Strategic Planning, Agile, DevOps
Preferred skills
Harness Engineering, AI-augmented software delivery, Medical Imaging workflows (CT, DICOM, IHE), HIPAA
Technologies
Harness Engineering, AI-augmented workflows, automated test generation, coding agents
Responsibilities
Strategize software requirement and system design initiatives; oversee regulatory compliance and cybersecurity; direct software requirements and system design; integrate DFMEA into design phases; act as Security Owner; provide strategic direction for software maintenance; lead technical investigations for complaints and CAPA; define best practices and standards; pioneer Harness Engineering practices; participate in executive-level meetings; manage talent and team operations; mentor team members
Seniority
Manager, hands-on IC with team leadership