Job Title: Medical Equipment Calibration Specialist

Job Summary:

The Manager-Level Medical Equipment Calibration Specialist is responsible for overseeing the strategic planning, execution, and management of calibration and maintenance operations for medical devices across healthcare facilities. This role involves leading multidisciplinary teams, ensuring regulatory compliance, driving innovation, and aligning calibration activities with organizational goals to maintain the reliability, safety, and accuracy of medical equipment.

Key Responsibilities:

Strategic Planning and Leadership:

• Develop and implement strategies for managing calibration and maintenance of medical devices to ensure compliance and operational excellence.
• Define objectives, allocate resources, and set performance metrics for calibration activities.
• Monitor calibration program effectiveness and recommend enhancements to align with organizational goals.

Calibration Operations Oversight:

• Oversee the calibration of high-complexity medical devices, including imaging systems, patient monitors, and diagnostic tools.
• Ensure all calibration processes adhere to manufacturer specifications and regulatory standards.
• Establish preventive maintenance schedules to reduce downtime and enhance equipment reliability.

Regulatory Compliance and Quality Management:

• Ensure all calibration and maintenance activities comply with ISO 13485, IEC 60601, FDA requirements, and other regulatory standards.
• Prepare for and lead internal and external audits, maintaining audit readiness and documentation accuracy.
• Develop and enforce standard operating procedures (SOPs) for calibration operations.

Team Management and Development:

• Lead a team of calibration specialists, providing mentorship and fostering skill development.
• Conduct performance evaluations, identify training needs, and build a high-performing team.
• Delegate tasks effectively to ensure timely and high-quality completion of calibration activities.

Project Management:

• Plan and execute large-scale calibration projects, ensuring adherence to timelines, budgets, and quality standards.
• Collaborate with cross-functional teams to support the integration of calibration activities with broader operational goals.
• Report project outcomes, challenges, and metrics to senior leadership and stakeholders.

Stakeholder Engagement:

• Act as a primary liaison between the calibration team, clinical staff, and external stakeholders.
• Address operational challenges and propose solutions to improve equipment reliability and user satisfaction.
• Communicate progress, compliance updates, and key performance indicators (KPIs) to organizational leadership.

Innovation and Continuous Improvement:

• Research and implement emerging technologies, such as predictive maintenance and automation tools, to enhance calibration processes.
• Identify opportunities for workflow optimization and cost reduction.
• Drive initiatives to introduce innovative calibration techniques and tools.

Key Focus Areas:

• Strategic Leadership: Lead and manage calibration operations across facilities, aligning with organizational goals.
• Regulatory Compliance: Ensure adherence to industry standards and maintain audit readiness.
• Team Leadership: Build and manage a team of skilled calibration specialists.
• Innovation: Drive process improvements and implement emerging technologies.

Skills and Knowledge Required:

• Extensive knowledge of medical equipment calibration techniques and regulatory standards (e.g., ISO 13485, IEC 60601, FDA).
• Proficiency in advanced diagnostic tools and calibration equipment, such as flow analyzers, signal simulators, and electrical safety analyzers.
• Strong project management skills, including resource planning, budgeting, and risk management.
• Leadership and organizational skills to manage teams and align operations with strategic objectives.
• Analytical and problem-solving skills for addressing high-level technical and operational challenges.

Educational Qualifications:

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

Experience:

• 10+ years of experience in medical device calibration and maintenance, with at least 3-5 years in a managerial or leadership role.
• Proven track record of managing teams and overseeing large-scale calibration operations.

Tools and Technologies:

• Expertise in calibration management software and advanced diagnostic tools.
• Familiarity with predictive maintenance technologies and automation platforms.
• Knowledge of data analytics tools for performance monitoring and reporting.

Other Requirements:

• Exceptional decision-making and communication skills for managing teams and engaging stakeholders.
• Ability to prioritize and multitask in a dynamic healthcare environment.
• Willingness to travel occasionally for audits, multi-site operations, and training sessions.
• Commitment to maintaining safety, quality, and compliance in all calibration activities.