Sr Software Design Assurance Engineer
Core
Ensuring software quality, safety, and regulatory compliance for embedded medical devices (CGM) at the intersection of firmware and algorithm development.
Role type
Senior Software Design Assurance Engineer
Builds
High-quality embedded software for continuous glucose monitoring (CGM) systems
Domain
Medical devices / Biosensing technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
IEC 62304, 21 CFR Part 820, software design control, risk management, verification and validation (V&V), requirements analysis, embedded systems testing, change control, technical documentation (DHF artifacts)
Preferred skills
ASQ CSQE certification, CGM/wearable device experience, signal processing, real-time operating systems (RTOS), CI/CD pipelines, requirements management tools (Jama)
Technologies
Embedded development environments, RTOS, CI/CD pipelines, Jama
Responsibilities
Provide guidance on regulatory compliance (IEC 62304, 21 CFR Part 820); partner with firmware and algorithm teams to deliver embedded software; lead software development and validation processes; conduct risk management activities (anomalies, assessments, CAPA); review and approve software design control deliverables; author technical documentation; assess change control impacts; participate in design reviews and requirements analysis.
Seniority
Senior, hands-on IC