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.

We are seeking a motivated Sr. Associate Bioengineer / Bioengineer, Systems Integration to work at the intersection of immunoassay biology, engineering systems, and automated workflows on Spear Bio’s SPEAR S.W.I.F.T. platform. This is a broad, hands-on integration role—not narrowly scoped to testing alone. You will design and execute experiments, integrate and troubleshoot complex subsystems, interpret assay and instrument data, develop and automate workflows, and build the validation evidence that ensures our platforms deliver reliable, reproducible results.

This role carries a clear growth trajectory toward subject matter expert (SME) and lead systems bioengineer. We are looking for someone with the technical depth, independence, and learning velocity to grow into a technical leader—capable of independently owning integration strategy, driving quality and reliability across the platform, and mentoring junior engineers

This role is based on-site in our Woburn, MA headquarters 5 days/week.

Key Responsibilities

Systems Integration & Troubleshooting

• Integrate hardware, software, reagent, and consumable subsystems into cohesive automated workflows on the SPEAR S.W.I.F.T. platform, ensuring end-to-end functional alignment.

• Troubleshoot complex cross-domain issues—diagnosing whether failures originate from assay chemistry, liquid handling, thermal control, optical detection, software, or consumable interactions—and drive root cause resolution.

• Apply structured problem-solving methods (FMEA, Ishikawa, 5-why, DOE) to isolate failure modes and implement corrective actions.

• Lead root cause investigations for in-house and field failures; own corrective actions through to verification of effectiveness.

• Support engineering change order (ECO) implementation, retrofit execution, and design iteration feedback loops.

Experiment Design & Data Interpretation

• Design and execute experiments to characterize, validate, and optimize assay and instrument performance—including DOE-based studies on critical process parameters.

• Perform assay-level testing to assess reproducibility, robustness, sensitivity, and specificity in proteomic immunoassay and qPCR/nucleic acid applications.

• Conduct engineering-level testing of liquid handling accuracy/precision, thermal uniformity, optical calibration, and module-to-module integration.

• Interpret multi-layer data (assay curves, instrument logs, workflow telemetry) to draw actionable conclusions and drive design decisions.

• Define success criteria and acceptance specifications for workflow reproducibility, assay performance, and instrument qualification (IQ/OQ/PQ).

Workflow Automation & Development

• Develop and refine automated assay workflows on the SPEAR S.W.I.F.T. platform, translating manual protocols into robust, automated sequences.

• Write and maintain scripts for instrument control, workflow orchestration, data logging, and automated test execution (Python, C#, or similar).

• Build data analysis pipelines and dashboards to evaluate assay reproducibility, precision, throughput, and system reliability.

• Identify opportunities to apply automation and AI/ML tools to improve testing efficiency, anomaly detection, and data analysis.

Validation & Systematic Testing

• Develop and execute test strategies spanning assay-level validation and engineering subsystem qualification.

• Conduct end-to-end validation of automated workflows, ensuring biological performance is preserved under engineering constraints.