Associate Engineer / Senior Associate Engineer, Systems Design & Integration

Spear Bio, founded in 2021, is a well-funded and rapidly growing biotech start-up headquartered in Woburn, Massachusetts. Our proprietary technology, Successive Proximity Extension Amplification Reaction (SPEAR), is a novel wash-free immunoassay platform, offering unprecedented sensitivity. We are dedicated to revolutionizing early disease diagnosis and monitoring by providing scalable, ultrasensitive solutions that deliver unparalleled accuracy in measuring low-abundant biomarkers, enabling clinicians and researchers to improve patient outcomes and advance global health.

ASSOCIATE ENGINEER / SENIOR ASSOCIATE ENGINEER, SYSTEMS DESIGN & INTEGRATION

Spear Bio is seeking a hands-on and motivated Associate Engineer / Senior Associate Engineer, Systems Design & Integration to support the development and integration of software tools, data analysis platforms, and automated assay workflows within our next-generation ultrasensitive immunoassay platform. This role sits at the intersection of software development, data engineering, and bench-level assay execution—you will build and refine the data analysis and instrument control software that enables our platform, while maintaining enough hands-on assay familiarity to generate baseline data and understand the biological inputs that drive your software.

You will work closely with cross-functional teams helping to assemble, test, and refine complex systems. This is an exciting opportunity to gain broad, system-level experience while contributing to the advancement of a transformative life sciences platform.

KEY RESPONSIBILITIES:

SOFTWARE DEVELOPMENT & DATA ANALYSIS TOOLS

• 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.

SYSTEM INTEGRATION & VERIFICATION

• 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.

ASSAY EXECUTION & BASELINE DATA GENERATION

• 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.

DOCUMENTATION & COMPLIANCE

• 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.

QUALIFICATIONS:

EDUCATION & EXPERIENCE

• 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.

TECHNICAL SKILLS

• Proficiency in Python for data analysis, scripting, and application development. Experience with additional languages (C#, JavaScript, SQL) is a plus.

• Experience building or contributing to data analysis pipelines, LIMS systems, or scientific software applications in a regulated environment.

• Familiarity with 21 CFR Part 11 compliance requirements and software development under design controls (ISO 13485, FDA QSR). 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.

• Prior experience using liquid handling systems (e.g., Hamilton, Tecan, Formulatrix) is a plus.

• 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.

SOFT SKILLS

• Detail-oriented, with