Job Title: Biomedical Calibration Engineer
Job Summary:
The Senior Biomedical Calibration Engineer is responsible for leading advanced calibration, testing, and maintenance of biomedical devices, ensuring compliance with regulatory standards and organizational objectives. This role involves managing complex calibration tasks, mentoring team members, and driving process improvements to optimize operational efficiency and maintain the highest levels of accuracy and reliability.
Key Responsibilities:
Calibration and Testing:
- Lead advanced calibration of biomedical equipment, including ventilators, infusion pumps, defibrillators, imaging devices, and patient monitors.
- Validate and certify high-precision devices using advanced tools such as patient simulators, electrical safety analyzers, and imaging test equipment.
- Address and resolve complex calibration issues, ensuring all devices meet manufacturer specifications and regulatory standards.
Documentation and Reporting:
- Review and approve detailed calibration records, logs, and certificates to ensure compliance with ISO 13485 and ISO 17025.
- Prepare comprehensive calibration reports with actionable insights for stakeholders.
- Develop and refine calibration procedures to align with the latest industry advancements and best practices.
Maintenance and Troubleshooting:
- Supervise preventive maintenance programs for biomedical equipment and calibration tools to ensure consistent functionality.
- Diagnose and resolve advanced technical issues in biomedical devices, implementing corrective and preventive actions.
- Support the integration of new calibration methodologies, tools, and technologies into workflows.
Compliance and Quality Assurance:
- Ensure all calibration activities comply with relevant standards such as ISO 17025, ISO 13485, and IEC 60601.
- Act as a technical lead during internal and external audits, addressing compliance concerns and providing documentation.
- Drive initiatives to maintain certifications and improve quality control systems.
Team Leadership and Development:
- Mentor and train junior and mid-level engineers, fostering technical growth and professional development.
- Lead training sessions on advanced calibration techniques, safety protocols, and regulatory compliance.
- Collaborate with cross-functional teams on calibration-related projects, ensuring alignment with organizational goals.
Process Optimization and Innovation:
- Identify inefficiencies in calibration processes and lead efforts to enhance accuracy, efficiency, and productivity.
- Stay updated on emerging technologies in biomedical calibration and integrate innovative tools and practices.
- Participate in research and development initiatives to advance calibration methodologies and capabilities.
Skills and Knowledge Required:
- Advanced knowledge of biomedical equipment and calibration principles, including high-precision devices like imaging systems, ventilators, and defibrillators.
- Expertise in using advanced calibration tools such as electrical safety analyzers, signal simulators, patient simulators, and imaging calibration systems.
- Strong problem-solving and analytical skills to address complex calibration challenges and optimize processes.
- In-depth understanding of regulatory and quality standards, including ISO 17025, ISO 13485, and NIST traceability.
- Leadership skills to manage teams, lead projects, and ensure high-quality outcomes.
Educational Qualifications:
- Bachelor’s or Master’s degree in Biomedical Engineering, Electronics Engineering, or a related technical field.
- Advanced certifications in biomedical calibration, metrology, or regulatory compliance (e.g., ISO 17025 Lead Auditor) are highly desirable.
Key Focus Areas:
- Medical Device Control Systems: Leading the design, optimization, and troubleshooting of complex control systems for medical devices.
- Patient Monitoring Equipment: Overseeing advanced calibration, testing, and integration of patient monitoring systems.
- Regulatory Compliance: Driving compliance with FDA, ISO, and other global standards, ensuring documentation excellence and regulatory adherence.
- Calibration and Maintenance: Establishing protocols, managing preventative maintenance programs, and leading high-precision calibration efforts across diverse medical equipment.
Experience:
- 7-10 years of experience in biomedical calibration, with proven expertise in managing complex systems and projects.
- Demonstrated ability to lead and mentor teams while handling advanced calibration tasks.
Tools and Equipment:
- High-precision calibration tools, including patient simulators, electrical safety analyzers, imaging test equipment, and signal simulators.
- Familiarity with calibration management software for data analysis, scheduling, and reporting.
Other Requirements:
- Exceptional communication and leadership skills to engage with teams, clients, and stakeholders effectively.
- Commitment to maintaining safety, compliance, and operational excellence in calibration activities.
- Ability to manage multiple projects and deliver results under tight deadlines.
- Willingness to travel for high-priority projects and client consultations as needed.