Sr Manager SW Design Quality Engineering
Core
Leading software quality assurance, regulatory compliance, and partnerships for continuous glucose monitoring (CGM) devices.
Role type
Senior Manager, Software Quality Engineering
Builds
Validated medical device software and regulatory-compliant quality management systems
Domain
Medical Devices / Consumer Health Technology / Biosensing
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Software QA leadership, Regulatory compliance (IEC 62304, FDA), SDLC management, Risk assessment, CAPA management, Design reviews, Process improvement
Preferred skills
Modern programming languages, Cloud platforms (Azure, AWS, Google Cloud), Mobile and wearable software development, BI/AI platforms
Technologies
Azure, AWS, Google Cloud
Responsibilities
Align technology solutions with business objectives, manage the software development lifecycle (SDLC), ensure compliance with IEC 62304 and FDA guidance, prepare quality findings for executive management, collaborate on process improvements, lead risk assessments and health hazard assessments, maintain validated states and review change control documentation, participate in design reviews, identify compliance gaps and update procedures
Seniority
Senior Manager, hands-on leadership