Engineer, Systems Testing (Immunoassays & Instrumentation)

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 Systems Test Engineer to establish and execute systematic testing strategies across assay workflows and integrated engineering systems. This role requires a strong understanding of where immunoassays/nucleic acid assays and systems intersect, with the ability to design rigorous test frameworks, validate performance across biology and hardware/software interfaces, and identify root causes of failures. You will ensure that Spear Bio’s integrated platforms deliver reliable, reproducible, and high-quality results.

Key Responsibilities:

Systematic Test Design & Validation

• Develop and execute test strategies for assay-level validation (proteomic immunoassays, PCR/nucleic acid assays) and engineering subsystems.

• Define success criteria for workflow reproducibility, assay sensitivity/specificity, and instrument performance.

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

  Multi-Level Testing

• Perform assay-level testing to assess reproducibility, robustness, and sensitivity in proteomic and molecular biology applications.

• Conduct engineering-level testing of liquid handling, thermal control, optics, and module-to-module integration.

• Execute system-level testing of fully automated workflows combining assay and instrumentation.

  Troubleshooting & Continuous Improvement

• Differentiate whether performance issues arise from assay chemistry, workflow automation, or engineering subsystems.

• Apply structured methods (e.g., FMEA, root cause analysis) to resolve failures and improve robustness.

• Collaborate with assay and integration teams to implement corrective actions.

  Automation & Data Tools

• Develop automated test scripts for instrument control, workflow monitoring, and data logging.

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

• Generate dashboards and reports for system validation and assay performance metrics.

  Cross-Disciplinary Collaboration

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

• Work with integration engineers to ensure testability is built into system design.

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

Qualifications:

Education & Experience

• Master’s or Ph.D. in Biomedical Engineering, Bioengineering, Chemical Engineering, Systems Engineering, Mechanical/Electrical Engineering, or related field.

• 3-5 years of experience in systems test engineering, validation, or quality engineering specifically for immunoassays and nucleic acid assays required

  Technical Skills

• Strong foundation in structured test/validation methodologies at both biological and engineering levels.

• Hands-on experience testing assay workflows (proteomic immunoassays, PCR/nucleic acid amplification) on automated platforms (prior experience in FAST/qPCR is preferred).

• Experience with liquid handling automation, mechatronic instruments, or integrated life science systems.

• Programming/scripting skills (Python, C#, or similar) for test automation and data analysis.

• Familiarity with statistical analysis and data visualization for assay and system performance.

Soft Skills:

• Strong analytical mindset and systematic approach to problem-solving.

• Excellent documentation and communication skills.

• Ability to collaborate across scientific and engineering teams in a fast-paced environment.

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.