Associate Engineer / Senior Associate Engineer, Systems Design & Integration

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 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 to accelerate software development, code review, and test automation.
• Ensure all software development follows 21 CFR Part 11 compliance principles.

System Integration & Verification

• Assist with the integration of hardware, software, and reagent components into a cohesive immunoassay platform.
• Collaborate with internal teams and external partners to troubleshoot technical issues related to subsystems, consumables, and instrumentation.
• 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.

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 sufficient to independently execute standard protocols and interpret assay results.
• Translate bench-level assay insights into software requirements.

Documentation & Compliance

• Maintain organized 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 practices align with ISO 13485 and FDA QSR design control expectations.

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 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).
• 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.
• Prior experience using liquid handling systems is a plus.
• Working knowledge of CAD tools 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 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.