Job Title: Medical Instrumentation Engineer

Job Summary:

The Junior Medical Instrumentation Engineer is responsible for performing routine calibration, maintenance, and troubleshooting of medical devices and systems. This role involves ensuring compliance with regulatory standards, supporting the integration of medical equipment, and collaborating with clinical teams to ensure reliable device performance. The engineer works with minimal supervision to address technical challenges and enhance the operational efficiency of medical instrumentation.

Key Responsibilities:

Calibration and Maintenance:

• Perform routine calibration and maintenance of medical devices, including patient monitors, ventilators, infusion pumps, and imaging systems.
• Conduct performance tests to ensure equipment operates within defined accuracy and reliability standards.
• Maintain detailed records of calibration, testing, and maintenance activities for compliance and audits.

Troubleshooting and Diagnostics:

• Diagnose and resolve minor technical issues in medical instrumentation independently.
• Use diagnostic tools and software to analyze equipment performance and implement corrective actions.
• Escalate complex technical challenges to senior engineers or vendors as needed.

System Integration and Support:

• Assist in the installation, configuration, and integration of medical devices within healthcare facilities.
• Ensure seamless functionality of medical device control systems, including software and hardware components.
• Collaborate with clinical staff to ensure equipment meets operational needs and performance expectations.

Regulatory Compliance and Quality Assurance:

• Ensure compliance with FDA, ISO 13485, and other applicable standards during maintenance and testing activities.
• Participate in internal audits and prepare documentation required for regulatory inspections.
• Contribute to the continuous improvement of quality assurance processes for medical devices.

Learning and Development:

• Enhance knowledge of medical instrumentation principles, including sensors, actuators, and control systems.
• Stay updated on advancements in medical device technologies and regulatory requirements.
• Attend training sessions and workshops to improve technical skills and understanding of healthcare environments.

Key Focus Areas:

• Device Maintenance: Perform calibration and testing of medical devices to ensure accurate and reliable performance.
• Troubleshooting: Independently resolve minor issues in medical instrumentation and support complex troubleshooting efforts.
• Compliance: Ensure adherence to regulatory standards and maintain accurate documentation.
• Collaboration: Work closely with clinical teams to support the effective use of medical devices.

Skills and Knowledge Required:

• Solid understanding of medical device control systems and patient monitoring equipment.
• Basic troubleshooting skills for resolving issues with medical instrumentation.
• Familiarity with regulatory standards (e.g., FDA, ISO 13485) and quality management systems.
• Proficiency in using calibration tools and diagnostic equipment for medical devices.
• Strong communication and teamwork skills to collaborate effectively with clinical and technical teams.

Educational Qualifications:

• Bachelor’s degree in Biomedical Engineering, Instrumentation Engineering, Electronics Engineering, or a related technical field.
• Certifications in medical device maintenance or compliance (e.g., ISO 13485, FDA compliance basics) are desirable.

Experience:

• 1-2 years of experience in maintaining and troubleshooting medical devices, preferably in healthcare or related industries.

Tools and Technologies:

• Proficiency in using calibration tools such as signal simulators, electrical safety analyzers, and flow meters.
• Familiarity with patient monitoring systems, infusion pumps, ventilators, and imaging equipment.
• Basic knowledge of data analysis tools and software for logging and evaluating device performance.

Other Requirements:

• Strong attention to detail and ability to work independently on routine tasks.
• Willingness to work in healthcare settings and comply with safety and hygiene protocols.
• Commitment to maintaining safety, quality, and regulatory compliance in all activities.