Associate Engineer / Senior Associate Engineer, Systems Design & Integration

Summary

Spear Bio is a biotech startup developing an ultrasensitive immunoassay platform for disease diagnosis and monitoring. The Associate Engineer / Senior Associate Engineer will develop and integrate software tools, data analysis platforms, instrument controls, and automated assay workflows while supporting system verification and hands-on assay execution. The role also involves maintaining regulated documentation, troubleshooting subsystem issues, and translating assay insights into software requirements.

Responsibilities

• 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 the development and maintenance of Spear Bio’s LIMS (Laboratory Information Management System) 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, working with firmware and application-layer interfaces to ensure reliable automated workflows
• Leverage AI-assisted development tools (e.g., GitHub Copilot, Claude, ChatGPT) to accelerate software development, code review, and test automation—and proactively identify new opportunities to apply AI tools to engineering workflows
• Ensure all software development follows 21 CFR Part 11 compliance principles, including audit trails, electronic signatures, data integrity, and access controls where applicable
• Assist with the integration of hardware, software, and reagent components into a cohesive immunoassay platform, ensuring functional alignment across subsystems
• Collaborate with internal teams and external partners to troubleshoot technical issues related to subsystems, consumables, and instrumentation (e.g., liquid handlers, sensors, and robotics)
• Execute system integration and verification test protocols; document results and support the development of technical reports and design documentation
• Identify and address system-level issues; contribute to continuous improvement initiatives for workflow robustness and operational efficiency
• Perform baseline assay runs on the SPEAR platform to generate reference data for software validation, calibration development, and performance benchmarking
• Develop a working understanding of SPEAR assay workflows (sample preparation, plate setup, qPCR readout, SPEARview data analysis) sufficient to independently execute standard protocols and interpret assay results
• Translate bench-level assay insights into software requirements—ensuring that data analysis tools accurately reflect the biology they are designed to process
• Maintain organized records of system configurations, integration workflows, software versions, and experimental outcomes
• Support calibration, maintenance, and review of system performance for development and pilot-scale platforms
• Contribute to root cause investigations and system refinements to enhance usability, scalability, and reliability
• Ensure documentation practices align with ISO 13485 and FDA QSR design control expectations where applicable

Skills

• Bachelor's or Master's degree in Bioengineering, Biomedical Engineering, Computer Science, Bioinformatics, or a related discipline
• 1–4 years of experience with lab systems integration, software development for scientific instruments, or diagnostics platform development
• Proficiency in Python for data analysis, scripting, and application development
• Experience building or contributing to data analysis pipelines, LIMS systems, or scientific software applications in a regulated environment
• Direct experience is preferred
• Foundational understanding is required
• Hands-on experience or strong willingness to learn assay execution for plate-based immunoassays, qPCR workflows, or similar biological assays
• Experience with or enthusiasm for AI-assisted development tools and their application to engineering and data analysis workflows
• Working knowledge of CAD tools (e.g., SolidWorks) and familiarity with diagnostic laboratory instruments and life science automation systems
• Familiarity with version control (Git), CI/CD concepts, and collaborative development practices
• Detail-oriented, with strong organizational and documentation skills
• Effective communicator and team player, able to collaborate in a fast-paced, interdisciplinary environment
• Self-motivated learner comfortable bridging software engineering and wet-lab biology
• Comfortable working in a startup environment where scope evolves rapidly and initiative is valued
• Experience with additional languages (C#, JavaScript, SQL) is a plus
• Prior experience using liquid handling systems (e.g., Hamilton, Tecan, Formulatrix) is a plus

Qualifications

Must Haves

• Bachelor's or Master's degree in Bioengineering, Biomedical Engineering, Computer Science, Bioinformatics, or a related discipline
• 1–4 years of experience with lab systems integration, software development for scientific instruments, or diagnostics platform development
• Proficiency in Python for data analysis, scripting, and application development
• Experience building or contributing to data analysis pipelines, LIMS systems, or scientific software applications in a regulated environment
• Direct experience is preferred
• foundational understanding is required
• Hands-on experience or strong willingness to learn assay execution for plate-based immunoassays, qPCR workflows, or similar biological assays
• Experience with or enthusiasm for AI-assisted development tools and their application to engineering and data analysis workflows
• Working knowledge of CAD tools (e.g., SolidWorks) and familiarity with diagnostic laboratory instruments and life science automation systems
• Familiarity with version control (Git), CI/CD concepts, and collaborative development practices
• Detail-oriented, with strong organizational and documentation skills
• Effective communicator and team player, able to collaborate in a fast-paced, interdisciplinary environment
• Self-motivated learner comfortable bridging software engineering and wet-lab biology
• Comfortable working in a startup environment where scope evolves rapidly and initiative is valued

Nice to Haves

• Experience with additional languages (C#, JavaScript, SQL) is a plus
• Prior experience using liquid handling systems (e.g., Hamilton, Tecan, Formulatrix) is a plus