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 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.

We offer competitive compensation, meaningful stock ownership, comprehensive benefits, and a great work environment. This is an opportunity to enter an innovative, high-growth startup at an early stage and play an integral role in the company's growth and success. We are focused on identifying candidates who have demonstrated leadership and excellence throughout their careers and are excited by the prospect of building an industry-leading company.

Spear Bio Inc. provides equal opportunity in employment to all persons. No person shall be denied equal access because of race, creed, color, religion, national origin, sex, sexual orientation, gender identity, age, or physical/mental disability.

Spear Bio does not accept resume submissions from external recruiting agencies. Any unsolicited resumes or candidate information submitted without prior written agreement will be deemed the property of Spear Bio, and no placement fees will be paid.