Senior Associate Bioengineer/Bioengineer, Automation & Systems Testing

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.