Job Title: Clinical Instrumentation Technician

Job Summary:

The Supervisor-Level Clinical Instrumentation Technician is responsible for overseeing the maintenance, calibration, and repair of clinical devices and instrumentation within healthcare facilities. This role involves supervising a team of technicians, ensuring compliance with regulatory standards, managing daily operations, and contributing to strategic initiatives for improving device reliability and operational efficiency.

Key Responsibilities:

Team Leadership and Supervision:

• Oversee and coordinate the daily activities of a team of clinical instrumentation technicians.
• Assign tasks, monitor progress, and ensure timely completion of maintenance and repair schedules.
• Conduct performance evaluations, provide feedback, and identify training needs for team development.

System Maintenance and Calibration:

• Supervise the calibration, preventive maintenance, and performance testing of advanced clinical devices, including imaging systems, patient monitors, infusion pumps, and ventilators.
• Ensure all devices are maintained according to manufacturer specifications and regulatory standards.
• Develop and enforce preventive maintenance schedules to minimize downtime.

Troubleshooting and Diagnostics:

• Provide advanced technical support for resolving complex device malfunctions and system errors.
• Guide team members in diagnosing and troubleshooting equipment issues using advanced diagnostic tools.
• Collaborate with vendors and manufacturers to address critical or escalated technical challenges.

Regulatory Compliance and Documentation:

• Ensure all team activities comply with FDA, ISO 13485, IEC 60601, and other healthcare standards.
• Oversee the maintenance of accurate service logs, calibration records, and compliance documentation.
• Prepare for and participate in internal and external audits.

Device Integration and Project Oversight:

• Supervise the installation, configuration, and commissioning of new clinical devices and systems.
• Ensure seamless integration of new devices into existing workflows, maintaining compatibility and functionality.
• Oversee retrofitting and upgrade projects to bring legacy systems in line with current technologies and standards.

Collaboration and Communication:

• Act as the primary point of contact between the technical team and clinical staff to address operational concerns.
• Communicate regularly with healthcare teams to ensure devices meet clinical needs and performance expectations.
• Provide updates and reports to management on team performance, system reliability, and compliance metrics.

Process Improvement and Innovation:

• Identify opportunities to optimize workflows and improve the reliability of clinical devices.
• Implement innovative tools, technologies, and practices to enhance operational efficiency.
• Drive initiatives to automate maintenance processes and introduce predictive maintenance techniques.

Key Focus Areas:

• Leadership: Supervise and mentor a team of technicians, ensuring high performance and adherence to standards.
• System Oversight: Ensure the maintenance, calibration, and reliability of all clinical devices.
• Compliance and Quality: Maintain adherence to regulatory standards and ensure accurate documentation.
• Process Optimization: Drive efficiency and innovation in device maintenance and operations.

Skills and Knowledge Required:

• Strong understanding of clinical instrumentation, including imaging devices, ventilators, patient monitors, and diagnostic tools.
• Proficiency in advanced diagnostic tools and calibration equipment.
• Knowledge of healthcare regulatory standards, such as FDA, ISO 13485, and IEC 60601.
• Leadership and team management skills to supervise and develop technical staff.
• Analytical skills for evaluating device performance and implementing process improvements.

Educational Qualifications:

• Diploma or Bachelor’s degree in Biomedical Engineering, Instrumentation Technology, Electronics, or a related technical field.
• Certifications in advanced device maintenance, quality management, or regulatory compliance (e.g., ISO 13485) are preferred.

Experience:

• 5-7 years of experience in clinical instrumentation, including leadership or supervisory roles.
• Demonstrated expertise in advanced maintenance, troubleshooting, and project management.

Tools and Technologies:

• Expertise in calibration tools, diagnostic equipment, and compliance management software.
• Familiarity with automation technologies and predictive maintenance tools.
• Working knowledge of project management tools and techniques.

Other Requirements:

• Strong organizational and decision-making skills to manage multiple tasks and priorities effectively.
• Excellent communication skills for engaging with teams, clinical staff, and management.
• Willingness to travel occasionally to oversee multi-site operations or participate in training sessions.
• Commitment to maintaining the highest standards of quality, safety, and compliance.