Job Title: Medical Instrumentation Engineer

Job Summary:

The Medical Instrumentation Engineer at the fresher level is responsible for assisting in the design, calibration, and maintenance of medical devices and systems. This role involves gaining hands-on experience with patient monitoring equipment, control systems, and compliance with regulatory standards such as FDA and ISO. The engineer will work under the supervision of senior staff to ensure medical devices are functional, accurate, and safe for use in healthcare environments.

Key Responsibilities:

Calibration and Maintenance:

• Assist in the calibration, testing, and maintenance of medical devices, including patient monitoring systems, infusion pumps, and imaging equipment.
• Ensure equipment operates within specified performance parameters by conducting regular performance checks.
• Document calibration activities and maintain detailed service logs.

System Support and Troubleshooting:

• Support the installation, configuration, and troubleshooting of medical device control systems.
• Assist in diagnosing and resolving basic issues in medical instrumentation under supervision.
• Learn to use diagnostic tools and software for evaluating equipment performance.

Regulatory Compliance and Documentation:

• Adhere to FDA, ISO 13485, and other applicable standards during maintenance and testing activities.
• Assist in preparing compliance reports and maintaining documentation for audits and inspections.
• Participate in training sessions on medical device regulations and safety standards.

Learning and Development:

• Gain familiarity with medical instrumentation principles, including sensors, transducers, and control systems.
• Attend workshops and training sessions to build expertise in medical device technology and regulatory compliance.
• Shadow senior engineers to understand advanced maintenance and troubleshooting techniques.

Collaboration and Support:

• Work closely with clinical staff to understand equipment usage and performance expectations.
• Support cross-functional teams in the development and validation of new medical devices.
• Assist in ensuring the availability and readiness of medical equipment during clinical operations.

Key Focus Areas:

• Calibration and Maintenance: Ensure the accuracy and reliability of medical equipment through regular calibration and performance checks.
• Compliance: Support adherence to FDA, ISO, and other regulatory standards for medical devices.
• Learning and Development: Build foundational knowledge of medical instrumentation and device control systems.
• System Support: Assist in troubleshooting and resolving issues with patient monitoring and control systems.

Skills and Knowledge Required:

• Basic understanding of medical device control systems and patient monitoring equipment.
• Awareness of regulatory compliance standards (e.g., FDA, ISO 13485).
• Familiarity with calibration tools and techniques for medical instrumentation.
• Strong analytical and problem-solving skills for identifying and addressing system issues.
• Effective communication skills to collaborate with clinical staff and technical teams.

Educational Qualifications:

• Bachelor’s degree in Biomedical Engineering, Instrumentation Engineering, Electronics Engineering, or a related technical field.
• Basic certifications in medical device maintenance or regulatory compliance (e.g., FDA basics) are advantageous but not mandatory.

Experience:

• No prior experience required; internships or academic projects related to medical devices are beneficial.

Tools and Technologies:

• Exposure to calibration and diagnostic tools for medical devices, such as signal simulators and electrical safety analyzers.
• Familiarity with patient monitoring systems, infusion pumps, and imaging equipment.
• Basic knowledge of data logging and analysis software is a plus.

Other Requirements:

• Strong attention to detail and a commitment to maintaining high standards of safety and accuracy.
• Eagerness to learn and adapt to the dynamic environment of medical instrumentation.
• Willingness to work in healthcare settings and adhere to hygiene and safety protocols.