Job Description
Job Title: Lab Automation Software Engineer – Clinical Laboratory
Job Summary:
We are seeking a highly skilled and detail-orientedLab Automation Software Engineerto support the development, integration, and optimization of software-driven automation systems within ourhigh-complexity clinical laboratory. This role will play a critical part in scaling operations, improving throughput, and ensuring the reliability and compliance of automated testing platforms.
The ideal candidate will have a strong background insoftware development,instrument integration, andworkflow automation, along with a solid understanding ofclinical lab processes and regulatory requirements(CLIA, CAP, FDA). This is a cross-functional role that will work closely with the automation, informatics, lab operations, and quality teams.
Key Responsibilities:
Software Development & Integration
• Design, develop, and maintain custom software tools to automate laboratory workflows, instrument control, and data capture.
• Integrate laboratory instruments (e.g., liquid handlers, PCR machines, mass spectrometers, robotic arms) with Laboratory Information Management Systems (LIMS).
• Develop and deploy instrument drivers, APIs, and middleware to facilitate seamless data exchange between lab devices and backend systems.
Automation & Workflow Optimization
• Collaborate with lab scientists and engineers to automate sample processing steps, data transfer, and error handling.
• Translate wet lab SOPs into executable scripts or workflows using tools like Python, Java, or LabVIEW.
• Optimize existing automation protocols to reduce human error, improve efficiency, and enhance traceability.
Data Handling & Reporting
• Develop interfaces and pipelines for secure, real-time data collection and transfer to LIMS or EHR systems.
• Implement automated QC checks and reporting logic for test result validation.
• Support data logging, version control, and audit trail generation for compliance.
Validation & Compliance
• Support validation of automation workflows in accordance with CLIA, CAP, and FDA standards.
• Write and maintain technical documentation, including user manuals, software specifications, risk assessments, and validation protocols.
• Work closely with QA and Regulatory Affairs to ensure all systems are validated and compliant.
Required Qualifications:
• Bachelor’s or Master’s degree in Computer Science, Bioinformatics, Electrical Engineering, Biomedical Engineering, or related field.
• 3+ years of experience in lab automation software engineering, preferably in aclinical diagnostics or biotechsetting.
• Proficiency in programming languages such asPython, C#, Java, or LabVIEW.
• Experience integrating instruments usingserial, TCP/IP, or USB communication protocols, and parsingHL7 or ASTMdata formats.
• Familiarity withlaboratory automation platformssuch as Tecan, Hamilton, Beckman Coulter, or Opentrons.
• Solid understanding ofLIMS integrationand relational databases (e.g., PostgreSQL, MySQL, SQL Server).
• Knowledge ofCLIA, CAP, and FDA regulatory requirementsin a clinical lab environment.
Preferred Qualifications:
• Experience withrobotics control systemsandmachine vision technologies.
• Hands-on experience validating automated workflows in a CLIA-certified lab.
• Familiarity with agile development practices, GxP compliance, and software lifecycle documentation.
• Understanding of molecular diagnostic assays (e.g., qPCR, NGS, ELISA) and their automation.
• Experience with containerization (Docker), version control (Git), and CI/CD pipelines.
Work Environment:
• Fast-paced, high-complexity CLIA/CAP-accredited laboratory environment.
• Collaborative cross-functional teams including software, R&D, lab operations, and QA.
• Opportunities to work with cutting-edge lab instrumentation and next-generation diagnostics platforms.
• Hybrid on-site/remote flexibility depending on lab infrastructure and project needs.
Job Type: Full-time
Pay: $75,000.00 - $95,000.00 per year
Benefits:
• 401(k)
• Health insurance
• Paid time off
• Vision insurance
Work Location: In person