Job Title: Lab Management

Job Summary:
The Mid-Level Lab Management in the medical device field will oversee the calibration, maintenance, and testing of medical device control systems and patient monitoring equipment. This role ensures compliance with regulatory standards (FDA, ISO) and manages the overall operations of the lab, ensuring efficiency, accuracy, and the highest level of safety. The Lab Manager will provide leadership in managing lab staff, optimizing processes, and driving innovation to enhance the lab’s capabilities in line with industry standards.

Key Focus Areas:

1. Medical Device Control Systems:

   • Oversee the calibration, testing, and maintenance of medical device control systems to ensure they operate safely and efficiently.
   • Ensure that all control systems are up to date with the latest regulations and standards.
   • Troubleshoot and resolve issues with medical device control systems to ensure reliable functionality.

2. Patient Monitoring Equipment:

   • Manage the calibration and maintenance of patient monitoring equipment such as ECG, blood pressure monitors, and pulse oximeters.
   • Ensure that all equipment is properly tested, validated, and functioning correctly for patient safety.
   • Lead efforts to ensure monitoring systems are compliant with regulatory standards.

3. Regulatory Compliance (FDA, ISO standards):

   • Ensure that the laboratory complies with FDA and ISO standards for medical devices and equipment.
   • Conduct internal audits to ensure all testing and calibration processes meet the required quality and regulatory standards.
   • Prepare for external inspections and audits, ensuring all documentation is up to date and compliant.

4. Calibration and Maintenance of Medical Equipment:

   • Supervise the calibration and routine maintenance of medical devices and equipment to ensure operational accuracy.
   • Implement preventive maintenance schedules to reduce downtime and improve equipment reliability.
   • Ensure that all maintenance activities are logged and that calibration equipment is certified and properly maintained.

Key Responsibilities:

Leadership and Team Management:

• Lead a team of lab technicians and other staff, providing guidance, training, and support for technical and regulatory tasks.
• Allocate responsibilities and ensure efficient workflow in the lab.
• Foster a collaborative environment to encourage continuous improvement in lab operations.

Operational Oversight:

• Oversee day-to-day lab activities, ensuring all procedures are executed according to internal policies and external regulations.
• Monitor lab performance metrics and implement improvements to enhance productivity and accuracy in calibration and maintenance tasks.
• Ensure that all equipment is operational, certified, and compliant with regulatory standards.

Quality Assurance and Compliance:

• Lead quality control initiatives within the lab, ensuring compliance with FDA and ISO regulations.
• Maintain accurate documentation and records of calibration, testing, and maintenance activities.
• Perform audits and quality checks to ensure compliance with industry standards.

Training and Development:

• Provide training and mentoring to lab staff on new equipment, regulatory updates, and best practices for calibration and maintenance.
• Encourage staff development and maintain a high level of technical competence within the team.

Innovation and Continuous Improvement:

• Stay updated on advancements in medical device technologies and integrate new tools, systems, and methods into lab practices.
• Lead initiatives to improve lab processes, enhance testing methods, and ensure high-quality output.

Skills and Knowledge Required:

• In-depth knowledge of medical device control systems, patient monitoring equipment, and the calibration process.
• Expertise in FDA and ISO regulatory compliance and standards for medical devices.
• Experience in managing teams, with strong leadership and organizational skills.
• Proficiency in laboratory management systems and software for tracking equipment, calibration, and maintenance.
• Strong problem-solving abilities to address technical and operational challenges.

Educational Qualifications:

• Bachelor’s or Master’s degree in Biomedical Engineering, Medical Device Technology, or a related technical field.
• Certification in quality assurance, regulatory compliance, or lab management (e.g., ISO 13485, FDA 21 CFR) is highly desirable.

Experience:

• 3-5 years of experience in a laboratory or medical device-related field, with at least 3 years in a management or supervisory role.
• Hands-on experience in the calibration, maintenance, and testing of medical equipment and control systems.

Tools and Equipment:

• Experience with medical device calibration tools and monitoring systems.
• Familiarity with Laboratory Information Management Systems (LIMS) and maintenance tracking software.
• Expertise in using testing equipment and tools for medical device verification and validation.

Other Requirements:

• Strong communication skills to interact with stakeholders, clients, and regulatory bodies.
• Commitment to maintaining safety, quality, and compliance in all lab activities.
• Ability to travel for audits, client meetings, and industry events.