Job Title: Clinical Instrumentation Technician

Job Summary:

The Senior Clinical Instrumentation Technician is responsible for leading the maintenance, calibration, and optimization of complex clinical devices and systems in healthcare settings. This role involves managing advanced technical challenges, mentoring junior and mid-level technicians, and ensuring strict compliance with healthcare standards and regulations. The senior technician acts as a subject matter expert, providing guidance and oversight to ensure device reliability and operational excellence.

Key Responsibilities:

Advanced Maintenance and Calibration:

• Lead the calibration, preventive maintenance, and performance testing of complex clinical devices, including imaging systems, ventilators, patient monitors, and laboratory equipment.
• Develop and oversee maintenance schedules to ensure continuous device functionality and reliability.
• Ensure all devices operate within manufacturer and regulatory specifications through advanced calibration techniques.

Troubleshooting and Diagnostics:

• Diagnose and resolve complex technical issues using advanced diagnostic tools and methodologies.
• Conduct root cause analyses for recurring malfunctions and implement long-term corrective actions.
• Collaborate with vendors, manufacturers, and cross-functional teams to address critical device challenges.

Device Integration and Upgrades:

• Manage the installation, integration, and commissioning of new clinical devices across healthcare systems.
• Validate and ensure compatibility of devices with existing workflows and infrastructure.
• Lead retrofitting and upgrade projects to bring legacy systems in line with current technologies and standards.

Regulatory Compliance and Quality Assurance:

• Ensure all maintenance and operational activities comply with FDA, ISO, IEC, and other healthcare standards.
• Prepare for and lead internal and external audits, ensuring full compliance with quality and safety standards.
• Develop and refine standard operating procedures (SOPs) for clinical device maintenance and quality assurance.

Team Leadership and Mentorship:

• Provide technical leadership to junior and mid-level technicians, fostering skill development and knowledge sharing.
• Conduct training sessions to enhance the team’s proficiency in troubleshooting, maintenance, and compliance practices.
• Supervise the team’s daily activities to ensure quality and consistency in device management.

Collaboration and Stakeholder Engagement:

• Act as a primary technical resource for clinical staff, addressing device-related concerns and ensuring user satisfaction.
• Liaise with healthcare teams, vendors, and regulatory authorities to align device operations with organizational goals.
• Provide regular updates to management on device performance, compliance metrics, and operational challenges.

Innovation and Continuous Improvement:

• Drive innovation by integrating emerging technologies and methodologies into clinical device workflows.
• Identify opportunities for process improvements and implement solutions to enhance device reliability and reduce costs.
• Lead initiatives to automate maintenance workflows and implement predictive maintenance tools.

Key Focus Areas:

• Advanced Troubleshooting: Resolve complex issues to ensure the reliability of critical clinical devices.
• Leadership: Mentor team members and provide technical oversight for all instrumentation activities.
• System Integration: Oversee the deployment and validation of new devices, ensuring seamless integration.
• Regulatory Compliance: Maintain strict adherence to healthcare standards and manage audit processes.

Skills and Knowledge Required:

• Advanced knowledge of clinical instrumentation, including imaging systems, ventilators, and diagnostic equipment.
• Strong understanding of regulatory compliance standards, such as FDA, ISO 13485, and IEC 60601.
• Expertise in troubleshooting and using advanced diagnostic tools (e.g., signal simulators, electrical safety analyzers, flow meters).
• Leadership and team management skills to oversee and mentor a technical team.
• Analytical skills for evaluating device performance and implementing process improvements.

Educational Qualifications:

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

Experience:

• 7-10 years of experience in clinical instrumentation, with proven expertise in advanced maintenance and troubleshooting.
• Demonstrated ability to lead projects and mentor technical teams.

Tools and Technologies:

• Proficiency in diagnostic and calibration tools for advanced clinical devices.
• Familiarity with automation technologies and predictive maintenance tools.
• Working knowledge of compliance management and reporting software.

Other Requirements:

• Strong organizational and decision-making abilities to manage complex technical tasks.
• Willingness to travel occasionally for site visits, audits, or training sessions.
• Commitment to maintaining the highest standards of quality, safety, and compliance.