Job Title: Medical Instrumentation Engineer

Job Summary:

The Mid-Level Medical Instrumentation Engineer plays a pivotal role in maintaining, troubleshooting, and optimizing medical devices and control systems in healthcare settings. This position involves managing calibration schedules, resolving technical challenges, and ensuring strict adherence to FDA and ISO standards. The engineer contributes to operational efficiency, leads system integration efforts, and collaborates with multidisciplinary teams to enhance patient care through reliable instrumentation.

Key Responsibilities:

System Maintenance and Calibration:

• Perform calibration and maintenance of advanced medical devices such as patient monitors, ventilators, infusion pumps, and imaging systems.
• Implement preventive maintenance plans to ensure continuous reliability and compliance with safety standards.
• Validate the accuracy and performance of medical devices, ensuring adherence to specifications.

Troubleshooting and Diagnostics:

• Diagnose and resolve moderate to complex issues in medical devices using diagnostic software and tools.
• Conduct root cause analysis for recurring faults and implement corrective and preventive actions.
• Collaborate with vendors and senior engineers to address advanced technical challenges.

System Integration and Device Management:

• Lead the installation, configuration, and integration of new medical devices into hospital or clinic systems.
• Validate system compatibility and ensure seamless operation across interconnected devices.
• Support device upgrades and retrofits to align older systems with current regulatory and operational standards.

Regulatory Compliance and Quality Assurance:

• Ensure calibration and maintenance activities comply with FDA, ISO 13485, and other regulatory standards.
• Maintain accurate documentation of all service activities and participate in audits and inspections.
• Support the development and refinement of quality management systems and procedures.

Collaboration and Support:

• Work with healthcare professionals to ensure medical devices meet clinical needs and performance expectations.
• Provide technical support during device operation and training to clinical staff.
• Act as a key resource for cross-functional teams addressing operational and technical challenges.

Project Management and Mentorship:

• Manage mid-scale projects involving device installations, upgrades, or process optimization.
• Mentor junior engineers and technicians, providing technical guidance and knowledge transfer.
• Monitor and report project progress, ensuring alignment with organizational goals and timelines.

Key Focus Areas:

• Device Maintenance: Independently manage calibration and performance optimization for medical devices.
• System Troubleshooting: Resolve moderate to complex technical issues effectively and efficiently.
• Compliance and Documentation: Maintain stringent adherence to regulatory standards and accurate service records.
• Collaboration and Leadership: Work closely with clinical teams and provide mentorship to junior staff.

Skills and Knowledge Required:

• Proficiency in maintaining and troubleshooting medical devices, including patient monitors, imaging systems, and infusion pumps.
• Strong understanding of regulatory compliance standards such as FDA, ISO 13485, and other healthcare regulations.
• Knowledge of diagnostic tools and calibration equipment used in medical instrumentation.
• Ability to read and interpret technical documentation, schematics, and regulatory guidelines.
• Effective communication and collaboration skills for interacting 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 regulatory compliance (e.g., ISO 13485, FDA regulations) are preferred.

Experience:

• 3-5 years of experience in medical instrumentation roles, focusing on maintenance, troubleshooting, and compliance.

Tools and Technologies:

• Proficiency with calibration tools such as signal simulators, electrical safety analyzers, and flow meters.
• Familiarity with patient monitoring systems, ventilators, and imaging equipment.
• Working knowledge of software tools for data analysis and compliance tracking.

Other Requirements:

• Strong analytical and problem-solving skills to resolve technical challenges effectively.
• Ability to work independently while managing multiple priorities in a dynamic environment.
• Willingness to work in healthcare settings and adhere to safety protocols.
• Commitment to maintaining quality, safety, and compliance in all activities.