Associate Engineer – Systems Design & Integration

Spear Bio

. Develop and maintain data analysis software and tools for the SPEAR platform, including assay data processing pipelines, calibration curve fitting, and results reporting .

Posted 9/29/2026full-timeWoburn • Massachusetts • United StatesSenior💰 $105,000 - $115,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in software development for scientific instruments, with a strong focus on data analysis, compliance with 21 CFR Part 11, and integration of laboratory systems. Proficient in Python and familiar with AI-assisted development tools, ensuring high-quality software solutions in a regulated environment.

Highest-signal resume keywords

Python ProficiencyData Analysis Pipeline Development21 CFR Part 11 ComplianceLIMS Systems ExperienceAssay Execution Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PythonC#JavaScriptSQLData AnalysisSoftware DevelopmentAssay ExecutionSystem IntegrationCalibration Curve FittingAutomated Reporting

Soft Skills

Detail-OrientedStrong Organizational SkillsEffective CommunicationTeam PlayerSelf-Motivated Learner

Tools & Technologies

LIMSAI-Assisted Development ToolsLiquid Handling SystemsCAD ToolsVersion Control (Git)

Certifications & Qualifications

ISO 13485 ComplianceFDA QSR Compliance

Industry Keywords

BioengineeringBiomedical EngineeringImmunoassayQPCR WorkflowsDiagnostics Platform Development

Tech Stack

Tools & technologies

JavaScriptPythonSQL

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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 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
Foundational understanding of 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 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
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
Must be legally authorized to work in the US; visa sponsorship requirements addressed in application

Benefits

Comp & perks

Meaningful stock ownership/equity
Bonus
Comprehensive benefits
Great work environment