Spear Bio

Systems Engineer

• Develop and maintain data analysis software and tools for the SPEAR platform, including assay data processing pipelines, calibration curve fitting, and results reporting
• Contribute to Spear Bio’s LIMS infrastructure, ensuring data integrity, traceability, and regulatory compliance
• Build and improve dashboards, visualization tools, and automated reporting for assay performance metrics and system quality tracking
• Support instrument control software development and integration with firmware and application-layer interfaces
• Leverage AI-assisted development tools to accelerate software development, code review, and test automation
• Ensure software development follows 21 CFR Part 11 compliance principles
• Integrate hardware, software, and reagent components into a cohesive immunoassay platform
• Collaborate with internal teams and external partners to troubleshoot subsystems, consumables, and instrumentation
• Execute system integration and verification test protocols; document results and support technical reports and design documentation
• Identify and address system-level issues and contribute to continuous improvement
• Perform baseline assay runs to generate reference data for software validation, calibration development, and performance benchmarking
• Execute standard SPEAR assay protocols and interpret assay results
• Translate bench-level assay insights into software requirements
• Maintain records of system configurations, integration workflows, software versions, and experimental outcomes
• Support calibration, maintenance, and review of system performance
• Contribute to root cause investigations and system refinements
• Ensure documentation aligns with ISO 13485 and FDA QSR design control expectations

Associate Engineer – Systems Design & Integration