Job Title: Biomedical Calibration Engineer
Job Summary:
The Mid-Level Biomedical Calibration Engineer is responsible for independently performing and managing the calibration, testing, and maintenance of biomedical equipment. This role includes troubleshooting complex calibration issues, optimizing workflows, and ensuring compliance with regulatory standards. The Mid-Level Engineer provides technical expertise, supports large-scale projects, and mentors junior engineers and technicians.
Key Responsibilities:
Calibration and Testing:
- Perform advanced calibration of biomedical devices, including infusion pumps, patient monitors, defibrillators, ventilators, and imaging equipment.
- Validate and certify the performance of devices using specialized tools like electrical safety analyzers, signal simulators, and patient simulators.
- Diagnose and resolve calibration deviations, ensuring all instruments meet manufacturer and regulatory standards.
Documentation:
- Maintain detailed and accurate calibration records, including logs, certificates, and compliance documentation.
- Prepare calibration reports with technical insights and recommendations for performance improvement.
- Refine and update calibration procedures to align with the latest best practices and technological advancements.
Maintenance and Troubleshooting:
- Perform preventive maintenance on biomedical equipment and calibration tools to ensure consistent performance.
- Diagnose and resolve complex issues in biomedical devices, minimizing downtime and ensuring patient safety.
- Support the integration of new tools, methods, and technologies into calibration workflows.
Compliance and Quality Assurance:
- Ensure all calibration activities comply with regulatory standards such as ISO 17025, ISO 13485, and IEC 60601.
- Participate in internal and external audits, providing technical documentation and addressing compliance inquiries.
- Implement corrective and preventive actions to maintain high-quality standards in calibration processes.
Team Collaboration and Leadership:
- Collaborate with cross-functional teams on calibration projects and organizational objectives.
- Mentor and guide junior engineers and technicians, fostering their professional growth and technical expertise.
- Lead training sessions on advanced calibration techniques and equipment usage.
Process Optimization:
- Evaluate and optimize existing calibration workflows to improve efficiency, accuracy, and productivity.
- Stay updated on emerging calibration technologies and integrate new solutions to enhance operational capabilities.
Skills and Knowledge Required:
- Comprehensive understanding of biomedical equipment and its calibration, including ventilators, defibrillators, infusion pumps, and ECG machines.
- Proficiency in using advanced calibration tools like electrical safety analyzers, signal simulators, and patient simulators.
- Familiarity with quality and regulatory standards such as ISO 13485, ISO 17025, and NIST traceability.
- Strong troubleshooting and problem-solving skills for complex biomedical equipment issues.
- Analytical and organizational skills to manage multiple projects and prioritize tasks effectively.
Educational Qualifications:
- Bachelor’s degree or diploma in Biomedical Engineering, Electronics Engineering, or a related technical field.
- Advanced certification in biomedical calibration, metrology, or quality systems is highly desirable.
Experience:
- 3-5 years of experience in biomedical calibration or related fields.
- Proven ability to manage complex calibration tasks and mentor junior team members.
Key Focus Areas:
- Medical Device Control Systems: Expertise in managing and troubleshooting control systems for medical devices.
- Patient Monitoring Equipment: Calibration, testing, and maintenance of patient monitoring systems.
- Regulatory Compliance: Ensuring adherence to FDA and ISO standards in equipment calibration and documentation.
- Calibration and Maintenance: Performing precise calibration and preventative maintenance for various medical devices.
Tools and Equipment:
- Advanced calibration tools such as electrical safety analyzers, patient simulators, signal simulators, and imaging test equipment.
- Familiarity with calibration management software for documentation and scheduling is an advantage.
Other Requirements:
- Strong communication and collaboration skills to work with technical teams and healthcare stakeholders.
- Commitment to safety, compliance, and quality in all calibration activities.
- Ability to manage multiple projects, meet deadlines, and deliver high-quality results.
- Willingness to learn and adopt new calibration technologies and methodologies.