Job Title: Medical Equipment Calibration Specialist

Job Summary:

The Senior Medical Equipment Calibration Specialist is responsible for overseeing the calibration, maintenance, and optimization of complex medical devices and systems. This role involves leading calibration operations, managing compliance with regulatory standards, and mentoring junior and mid-level technicians. The senior specialist ensures high-quality, reliable performance of medical equipment and contributes to process improvements and innovation in healthcare technology.

Key Responsibilities:

Leadership in Calibration and Testing:

• Lead and perform advanced calibration and testing for medical devices, such as imaging systems, ventilators, patient monitors, and diagnostic tools.
• Define and implement calibration protocols that align with manufacturer specifications and regulatory standards.
• Ensure all devices meet performance benchmarks and maintain audit-ready calibration records.

System Maintenance and Optimization:

• Develop and oversee preventive maintenance strategies to enhance device reliability and minimize downtime.
• Identify and address potential risks or malfunctions in equipment through regular inspections and advanced diagnostics.
• Recommend and implement upgrades to improve the performance and longevity of medical devices.

Advanced Troubleshooting and Repairs:

• Diagnose and resolve complex technical issues in medical devices, utilizing advanced diagnostic tools and methodologies.
• Conduct root cause analysis for recurring equipment failures and implement long-term corrective actions.
• Collaborate with manufacturers, vendors, and regulatory bodies to address critical device challenges.

Regulatory Compliance and Quality Assurance:

• Ensure all calibration activities comply with global regulatory standards, including ISO 13485, IEC 60601, and FDA requirements.
• Lead internal and external audits, providing comprehensive documentation and ensuring compliance readiness.
• Refine and enforce standard operating procedures (SOPs) for calibration and quality assurance processes.

Team Leadership and Mentorship:

• Mentor junior and mid-level technicians, providing technical guidance and fostering skill development.
• Conduct training sessions to enhance the team's proficiency in calibration techniques and regulatory compliance.
• Supervise the work of team members to ensure adherence to quality standards and operational efficiency.

Innovation and Continuous Improvement:

• Research and implement emerging technologies to improve calibration processes and device performance.
• Lead initiatives to automate maintenance workflows and introduce predictive maintenance techniques.
• Propose and drive process improvements to enhance efficiency and reduce operational costs.

Key Focus Areas:

• Advanced Calibration Leadership: Lead the calibration of high-complexity medical devices and ensure compliance with regulations.
• System Optimization: Drive improvements in device performance, maintenance efficiency, and reliability.
• Team Development: Mentor and guide junior staff to enhance team capabilities and knowledge.
• Regulatory Compliance: Maintain strict adherence to regulatory standards and lead audit processes.

Skills and Knowledge Required:

• Advanced knowledge of medical equipment calibration, maintenance, and troubleshooting techniques.
• Proficiency in using sophisticated diagnostic tools such as flow analyzers, signal simulators, and electrical safety analyzers.
• In-depth understanding of regulatory compliance standards, including ISO 13485, IEC 60601, and FDA requirements.
• Leadership skills to manage teams and oversee complex technical projects.
• Analytical and problem-solving skills for diagnosing and addressing high-level technical challenges.

Educational Qualifications:

• Bachelor’s or Master’s degree in Biomedical Engineering, Electronics Engineering, Instrumentation, or a related technical field.
• Advanced certifications in medical equipment calibration, regulatory compliance, or quality management (e.g., ISO 13485, Lean Six Sigma) are highly desirable.

Experience:

• 7-10 years of experience in medical equipment calibration and maintenance, with proven expertise in handling complex systems.
• Demonstrated experience in leading teams and managing calibration operations.

Tools and Technologies:

• Proficiency with advanced calibration tools, including multimeters, flow analyzers, electrical safety analyzers, and gas flow meters.
• Familiarity with calibration management software and data analytics tools.
• Knowledge of predictive maintenance technologies and automation tools.

Other Requirements:

• Strong leadership and organizational skills to manage teams and complex projects effectively.
• Ability to work collaboratively with cross-functional teams, clinical staff, and external stakeholders.
• Willingness to travel occasionally for multi-site operations, audits, or training sessions.
• Commitment to maintaining safety, quality, and compliance in all activities.