Job Title: Medical Equipment Calibration Specialist

Job Summary:

The Mid-Level Medical Equipment Calibration Specialist is responsible for managing and performing advanced calibration, testing, and maintenance tasks for a variety of medical devices. This role involves independently resolving complex technical challenges, mentoring junior technicians, and ensuring strict compliance with industry regulations. The specialist works collaboratively with clinical and technical teams to maintain the accuracy and reliability of medical equipment in healthcare environments.

Key Responsibilities:

Advanced Calibration and Testing:

• Perform advanced calibration and functional testing of medical devices, such as patient monitors, ventilators, infusion pumps, and diagnostic systems.
• Develop and implement calibration protocols to ensure adherence to manufacturer and regulatory specifications.
• Verify and document equipment performance and generate detailed calibration reports for compliance.

Preventive Maintenance:

• Create and oversee preventive maintenance schedules to minimize downtime and ensure device reliability.
• Inspect and maintain medical equipment, addressing potential issues before they impact performance.
• Recommend part replacements and upgrades based on equipment condition and operational requirements.

Troubleshooting and Repairs:

• Diagnose and resolve complex technical issues using advanced diagnostic tools and methodologies.
• Conduct root cause analysis for recurring calibration discrepancies and implement corrective measures.
• Collaborate with manufacturers and vendors to address critical equipment issues and obtain technical support.

Regulatory Compliance and Quality Assurance:

• Ensure all calibration activities comply with regulatory standards such as ISO 13485, IEC 60601, and FDA requirements.
• Prepare and maintain comprehensive documentation for audits, inspections, and quality assurance processes.
• Actively participate in internal and external audits, ensuring full compliance with regulatory protocols.

Collaboration and Mentorship:

• Work closely with clinical staff to address equipment-related concerns and optimize device performance.
• Provide technical guidance and training to junior technicians, enhancing their calibration and troubleshooting skills.
• Collaborate with cross-functional teams to implement best practices in equipment maintenance and calibration.

Process Improvement and Innovation:

• Identify opportunities to streamline calibration processes and improve overall efficiency.
• Research and recommend new tools and technologies to enhance calibration accuracy and reliability.
• Implement innovative approaches to predictive maintenance and workflow optimization.

Key Focus Areas:

• Advanced Calibration: Lead and perform complex calibration tasks for medical devices.
• Maintenance Oversight: Manage preventive maintenance schedules and ensure equipment reliability.
• Compliance and Documentation: Maintain strict adherence to regulatory standards and provide audit-ready documentation.
• Mentorship and Collaboration: Support junior team members and work with clinical staff to address technical needs.

Skills and Knowledge Required:

• Advanced knowledge of medical equipment calibration techniques, tools, and protocols.
• Proficiency in using diagnostic tools, including multimeters, flow analyzers, pressure gauges, and electrical safety analyzers.
• Strong understanding of regulatory standards such as ISO 13485, IEC 60601, and FDA requirements.
• Analytical and problem-solving skills for addressing complex technical issues.
• Effective communication and leadership skills to mentor team members and collaborate with stakeholders.

Educational Qualifications:

• Bachelor’s degree in Biomedical Engineering, Electronics Engineering, Instrumentation, or a related technical field.
• Certifications in advanced calibration techniques, regulatory compliance, or quality management (e.g., ISO 13485, Lean Six Sigma) are preferred.

Experience:

• 3-5 years of experience in medical equipment calibration, testing, and maintenance.
• Proven ability to independently handle advanced calibration and troubleshooting tasks.

Tools and Technologies:

• Expertise in calibration tools such as gas flow analyzers, signal simulators, and electrical safety analyzers.
• Familiarity with software for calibration management and data analysis.
• Exposure to predictive maintenance tools and automation technologies is advantageous.

Other Requirements:

• Ability to manage multiple tasks and priorities effectively in a dynamic healthcare environment.
• Commitment to maintaining high standards of safety, quality, and compliance.
• Willingness to travel occasionally for training, audits, or multi-site equipment maintenance.