Chief Automation Officer – Clinical Diagnostics

The Chief Automation Officer (CAO) in Clinical Diagnostics is a senior executive responsible for leading the automation strategy, innovation, and integration of advanced technologies across clinical and diagnostic laboratories. The CAO oversees end-to-end automation – from pre-analytical workflows to post-analytical reporting – ensuring efficiency, compliance, scalability, and digital maturity across all operations.

Key Responsibilities:

• Develop and execute a comprehensive automation strategy aligned with diagnostic service goals and regulatory standards.

• Lead the implementation of laboratory automation systems including robotics, sample handling, conveyor systems, and auto-validation tools.

• Oversee data integration across LIS (Laboratory Information Systems), middleware, and enterprise-level software platforms.

• Identify and implement AI/ML and analytics tools to enhance diagnostic speed, quality, and decision-making.

• Drive vendor partnerships, technology selection, and ROI analysis for automation investments.

• Ensure compliance with CAP, CLIA, ISO 15189, FDA, and other regulatory standards.

• Build and lead a cross-functional team of automation engineers, process designers, IT specialists, and lab technologists.

• Support business scalability by standardizing lab processes across multiple sites and regions.

• Collaborate with R&D, operations, and quality teams to introduce next-gen diagnostics powered by automation and informatics.

Key Focus Areas:

1. End-to-End Laboratory Automation Strategy

   • Streamlining sample-to-result workflows: accessioning, aliquoting, testing, and archiving

   • Reducing manual intervention while increasing throughput and accuracy

2. Technology Integration & Digital Infrastructure

   • Seamless connection of instruments, LIS, EMR, and cloud systems

   • Enabling real-time tracking, traceability, and data harmonization

3. Operational Efficiency & Quality Improvement

   • Implementing KPIs for turnaround time (TAT), error rates, and sample handling

   • Driving Six Sigma/Lean initiatives in laboratory operations

4. Compliance & Risk Management

   • Ensuring system validation, audit readiness, and data integrity

   • Establishing SOPs for automated and semi-automated processes

5. Innovation & AI Enablement

   • Promoting intelligent automation through AI-powered image analysis, predictive maintenance, and decision support tools

   • Supporting integration of digital pathology, molecular automation, and genomics platforms

6. Leadership & Change Management

   • Building a culture of automation excellence and continuous improvement

   • Leading change initiatives, staff training, and stakeholder engagement

Qualifications:

• Education:

  • Master’s or Ph.D. in Biomedical Engineering, Clinical Laboratory Science, Automation, or related field

  • MBA or Executive Leadership certification (preferred)

• Experience:

  • 15+ years of experience in diagnostic lab automation or clinical technology management

  • Proven leadership in scaling automation in multi-site healthcare or diagnostics environments

• Technical Competencies:

  • Expertise in:

    • Total Laboratory Automation (TLA) platforms (e.g., Roche, Beckman Coulter, Abbott)

    • Integration with LIS (Sunquest, Cerner, Orchard)

    • Robotics, PLC/SCADA, and lab middleware systems

    • Quality systems (CAP/CLIA/ISO/FDA)

• Leadership Skills:

  • Visionary thinking, strong project management, and ability to drive cross-departmental initiatives

  • Excellent communication, financial acumen, and strategic planning abilities