The Clinical Engineering Manager – Lab Equipment is responsible for the planning, procurement, maintenance, calibration, and performance management of laboratory equipment and biomedical devices used in diagnostic and research laboratories. This role ensures that all lab instrumentation and systems meet safety, quality, and regulatory standards while supporting operational efficiency and minimizing equipment downtime.
The manager leads a team of biomedical engineers and technicians, collaborating with clinical, IT, and QA/QC teams to ensure seamless operation and support of lab systems, instrumentation, and automation platforms.
Oversee the life cycle management of laboratory and diagnostic equipment—from acquisition to decommissioning.
Lead the installation, preventive maintenance, calibration, and repair of lab instrumentation and automation systems.
Ensure compliance with regulatory standards such as CAP, CLIA, FDA, ISO 13485, 21 CFR Part 11, and The Joint Commission.
Develop and implement equipment maintenance programs and service-level agreements (SLAs).
Manage a team of clinical/biomedical engineers and external service vendors.
Maintain accurate equipment inventory, service records, and maintenance logs using CMMS.
Support equipment validation and qualification (IQ/OQ/PQ) and assist in commissioning new technologies.
Collaborate with procurement, laboratory staff, and vendors on equipment selection and contract negotiation.
Ensure data integrity, cybersecurity, and connectivity of smart lab devices with LIMS and LIS platforms.
Contribute to the design of laboratory layouts, facility upgrades, and infrastructure planning.
Lab Equipment Maintenance & Reliability
Preventive and corrective maintenance for analyzers, centrifuges, biosafety cabinets, freezers, incubators, PCR machines, etc.
Predictive analytics to reduce equipment failures and downtime.
Regulatory Compliance & Documentation
Maintain inspection readiness for CAP, CLIA, and other audits.
Ensure traceability, documentation control, and risk management (FMEA) practices are in place.
Calibration & Quality Control Systems
Manage calibration schedules for equipment measuring temperature, pressure, pH, conductivity, etc.
Ensure control systems function within defined tolerances and support QA programs.
Asset Lifecycle Management
Plan procurement, upgrades, and replacement cycles of lab instruments based on lifecycle analysis.
Conduct ROI assessments and technology evaluations for new instrumentation.
Lab Automation & Integration
Oversee technical aspects of integrating lab equipment with LIMS/LIS and building management systems (BMS).
Collaborate on robotics and instrument interfacing for automation of workflows.
Safety, Risk & Environmental Controls
Ensure lab equipment and related infrastructure comply with electrical, safety, and infection control standards.
Conduct risk assessments and enforce equipment-related safety protocols.
Team & Vendor Management
Supervise technical staff, assign priorities, and manage service contracts and vendor performance.
Conduct training on equipment handling, safety, and troubleshooting.
Education:
Bachelor’s or Master’s in Clinical Engineering, Biomedical Engineering, Electrical/Mechanical Engineering, or related field.
Certifications such as CBET (Certified Biomedical Equipment Technician) preferred.
Experience:
7–10 years of experience in clinical or laboratory equipment engineering and maintenance.
3–5 years in a leadership or supervisory role.
Experience in regulated environments (e.g., clinical labs, diagnostic centers, pharma labs).
Technical Skills:
Proficient in working with diagnostic analyzers, point-of-care devices, molecular testing instruments, etc.
Experience with CMMS, LIMS, and basic networking of lab equipment.
Knowledge of equipment validation, ISO 17025 calibration, and compliance systems.
Leadership & Soft Skills:
Strong communication, problem-solving, and team management skills.
Ability to work cross-functionally with lab operations, IT, QA, and procurement teams.