Senior Associate Bioengineer/Bioengineer, Automation & Systems Testing.

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.

• Design stress testing, boundary testing, and edge-case scenarios to identify latent failure modes.

• Generate validation documentation (protocols, reports, traceability matrices) consistent with ISO 13485 and FDA QSR design control expectations.

Cross-Disciplinary Collaboration & Growth

• Partner with assay scientists to align integration and test protocols with proteomic and nucleic acid assay requirements.

• Work with integration engineers, software developers, and field support to ensure testability and serviceability are built into system design.

• Collaborate with CDMO partners on manufacturing transfer validation and scalable test processes.

• Demonstrate independent learning and technical self-development—proactively building expertise across the platform stack without waiting for direction.

• Mentor junior team members on structured methodology, data rigor, and cross-domain thinking as you grow into the role.

Qualifications:

Education & Experience

• Master’s or Ph.D. in Biomedical Engineering, Bioengineering, Chemical Engineering, Systems Engineering, Mechanical/Electrical Engineering, or a related field. Exceptional Bachelor’s candidates with strong industry experience will be considered.

• 3–5 years of experience in systems integration, test engineering, validation, or applied R&D specifically involving immunoassays, nucleic acid assays, or integrated life science platforms. Industry experience in IVD, diagnostics, or life science instrumentation is required.

• Demonstrated track record of independently driving technical work—not just executing protocols defined by others.

Technical Skills

• Strong foundation in both biological assay workflows (proteomic immunoassays, qPCR/nucleic acid amplification) and engineering subsystems (liquid handling, thermal, optics, mechatronics).

• Hands-on experience with automated platforms (Hamilton, Tecan, Formulatrix, Roche, Bio-Rad, or similar). Prior experience with FAST-type liquid handlers and/or qPCR instruments is strongly preferred.

• Programming/scripting proficiency (Python required; C#, MATLAB, or similar a plus) for automation, data analysis, and pipeline development.

• Experience with experiment design (DOE), statistical analysis (SPC, Gage R&R), and data visualization.

• Understanding of regulated design controls (ISO 13485, FDA QSR, IEC 62304) and validation documentation practices.

Soft Skills & Growth Expectations

• Strong analytical mindset with the ability to think across the full stack—biology, workflow, instrument, and software—simultaneously.

• Excellent documentation and communication skills; able to write clear reports, present findings, and defend technical positions.

• Self-directed and proactive: comfortable operating with ambiguity, defining scope, and learning independently in a startup environment.

• Demonstrated ability to collaborate across scientific and engineering teams without silo thinking.

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.