Job Title: Biomedical Calibration Engineer
Job Summary:
The Junior Biomedical Calibration Engineer is responsible for performing calibration, testing, and maintenance of biomedical devices to ensure their accuracy and compliance with regulatory and quality standards. This role involves independently handling routine calibration tasks, maintaining detailed documentation, and assisting in troubleshooting and resolving issues in biomedical equipment.
Key Responsibilities:
Calibration and Testing:
- Conduct routine calibration of biomedical equipment such as infusion pumps, ventilators, patient monitors, and defibrillators.
- Validate the performance of devices using tools like electrical safety analyzers, signal simulators, and pressure meters.
- Address minor calibration issues and ensure equipment operates within specified tolerances.
Documentation:
- Maintain detailed and accurate calibration records, logs, and reports as per ISO 13485 and organizational standards.
- Generate calibration certificates and prepare compliance documentation for internal audits.
- Provide input to improve calibration procedures and templates.
Maintenance and Troubleshooting:
- Perform preventive maintenance on biomedical devices and calibration tools to ensure optimal performance.
- Assist in diagnosing and resolving common issues in biomedical equipment, escalating complex problems to senior engineers.
Compliance and Safety:
- Ensure all calibration activities comply with relevant standards such as ISO 17025, IEC 60601, and ISO 13485.
- Adhere to organizational safety protocols and best practices during calibration and testing tasks.
Team Collaboration:
- Work collaboratively with senior engineers and healthcare teams to meet calibration and maintenance objectives.
- Provide guidance to entry-level technicians and assist with their technical development.
Skills and Knowledge Required:
- Strong understanding of biomedical devices and their operational principles, including infusion pumps, ECG machines, and ventilators.
- Proficiency in using calibration tools like signal simulators, patient simulators, pressure meters, and electrical safety analyzers.
- Familiarity with quality and regulatory standards, such as ISO 13485 and ISO 17025.
- Basic troubleshooting and problem-solving skills for biomedical equipment issues.
- Attention to detail and a commitment to maintaining high-quality standards in calibration processes.
Educational Qualifications:
- Bachelor’s degree or diploma in Biomedical Engineering, Electronics Engineering, or a related technical field.
- Certification in biomedical calibration, metrology, or related fields is advantageous.
Experience:
- 1-3 years of experience in biomedical calibration or related fields.
- Practical experience with calibration tools and biomedical devices is required.
Key Focus Areas:
Calibration of Biomedical Equipment:
- Assist in performing routine calibration and validation of medical devices and equipment, including ECG machines, blood pressure monitors, and infusion pumps.
- Follow standardized procedures to calibrate biomedical devices, ensuring they meet operational and regulatory specifications.
Testing and Validation:
- Support testing and validation of biomedical devices, ensuring that equipment is functioning within the required accuracy and reliability parameters.
- Conduct functional and performance tests on medical equipment, documenting results and addressing any discrepancies.
Regulatory Compliance:
- Ensure that calibration, maintenance, and testing activities comply with industry regulations (FDA, ISO, etc.).
- Assist in preparing documentation for audits and maintaining calibration records in compliance with regulatory requirements.
Maintenance and Troubleshooting:
- Assist with routine preventive maintenance and troubleshooting of biomedical equipment to ensure continuous operation and minimize downtime.
- Work with senior engineers to diagnose and repair faulty equipment, following established procedures and safety guidelines.
Documentation and Reporting:
- Maintain detailed records of calibration, maintenance, and testing activities, ensuring accuracy and completeness of all documentation.
- Generate reports on calibration and testing results, highlighting any issues and corrective actions taken.
Tools and Equipment:
- Calibration tools such as electrical safety analyzers, signal simulators, pressure meters, and patient simulators.
- Familiarity with calibration management software for documentation and scheduling is a plus.
Other Requirements:
- Strong communication and teamwork skills to collaborate with technical teams and healthcare professionals.
- Commitment to adhering to safety protocols and maintaining compliance with regulatory standards.
- Willingness to learn advanced calibration techniques and stay updated on industry trends.