The Instrumentation and Control Manager – Clinical is responsible for overseeing all instrumentation, control systems, and automation infrastructure within clinical and diagnostic laboratories. This role ensures high availability, accuracy, and regulatory compliance of critical lab instrumentation and interfaces, supporting diagnostic quality, operational efficiency, and data integrity.
The manager leads a team of instrumentation engineers and technicians while collaborating with clinical staff, IT, QA, and vendors to maintain and improve lab systems used in areas such as clinical chemistry, hematology, immunology, molecular diagnostics, and microbiology.
Lead the maintenance, calibration, and performance optimization of clinical lab instrumentation.
Oversee installation, validation (IQ/OQ/PQ), and lifecycle management of lab equipment and control systems.
Ensure compliance with regulatory standards such as CAP, CLIA, FDA (21 CFR Part 11), and ISO 15189.
Develop and manage automation strategies and control systems for integrated laboratory workflows.
Supervise technical teams and coordinate with vendors for service, upgrades, and repairs.
Implement and manage instrument-to-LIS/LIMS integration, middleware configuration, and data interfaces.
Ensure robust documentation and audit readiness for all instrumentation systems.
Support lab expansions, facility upgrades, and control system standardization across labs.
Lead risk assessment and mitigation planning for instrumentation-related issues.
Clinical Lab Instrumentation Oversight
Manage analyzers for hematology, immunoassay, microbiology, molecular diagnostics, etc.
Ensure uptime and performance of high-throughput instruments and lab robotics.
Automation & Control Systems Integration
Deploy and maintain programmable logic controllers (PLCs), SCADA, and distributed control systems (DCS) in lab settings.
Integrate lab instruments with middleware, LIMS, and LIS platforms.
Calibration & Validation Compliance
Lead scheduled calibration and validation of critical instruments using ISO 17025/traceable standards.
Manage CSV (Computer System Validation) in accordance with GAMP 5 and 21 CFR Part 11.
Regulatory & Quality Systems Compliance
Maintain documentation and change controls to ensure inspection readiness for CAP, CLIA, FDA, and ISO audits.
Implement SOPs for instrument operation, maintenance, and control loop tuning.
Data Integrity & Instrument Connectivity
Ensure secure and accurate data transfer from lab instruments to LIS, EMR, and enterprise data systems.
Troubleshoot and manage bidirectional interfaces, HL7 messages, and API-based integrations.
Team & Vendor Management
Supervise instrumentation/control engineers and lab support staff.
Oversee vendor SLAs, service contracts, and capital project implementations.
Risk Management & Failure Response
Lead root cause analysis (RCA) and failure mode and effects analysis (FMEA) for critical equipment.
Establish business continuity plans for instrument outages.
Education:
Bachelor’s or Master’s degree in Instrumentation Engineering, Biomedical Engineering, Electrical Engineering, or a related field.
Certifications in control systems, automation, or clinical engineering preferred.
Experience:
8–12 years in clinical laboratory or healthcare instrumentation roles.
5+ years in a managerial or supervisory capacity in a regulated lab environment.
Experience with laboratory automation, PLCs/SCADA, and middleware systems.
Technical Skills:
Proficient in interfacing clinical instruments with LIS/LIMS systems (e.g., Abbott, Roche, Siemens, Beckman platforms).
Strong understanding of regulatory frameworks including CLIA, CAP, FDA 21 CFR Part 11, and ISO standards.
Familiarity with control loop tuning, PID control, and process instrumentation.
Leadership & Soft Skills:
Strong analytical, communication, and leadership skills.
Ability to coordinate across departments including IT, QA, Lab Operations, and Facilities.