Job Title: Biomedical Calibration Engineer
Job Summary:
The Manager-Level Biomedical Calibration Engineer oversees the strategic planning, execution, and optimization of calibration and maintenance activities for biomedical equipment across healthcare facilities. This role involves leading a multidisciplinary team, ensuring compliance with regulatory standards, driving innovation in calibration practices, and aligning operations with organizational objectives to guarantee the accuracy and reliability of medical devices.
Key Responsibilities:
Strategic Planning and Leadership:
- Develop and implement strategies for managing calibration and maintenance of biomedical devices, ensuring compliance with industry standards.
- Define team goals, allocate resources, and establish performance metrics to optimize calibration operations.
- Monitor calibration program effectiveness and recommend improvements to align with organizational objectives.
Calibration Operations Oversight:
- Oversee the calibration of advanced biomedical equipment, including diagnostic devices, life-support systems, and imaging equipment.
- Ensure preventive maintenance schedules are adhered to, minimizing downtime and enhancing device reliability.
- Lead efforts to integrate new calibration technologies and methodologies to improve accuracy and efficiency.
Regulatory Compliance and Quality Assurance:
- Ensure all calibration activities comply with global regulatory standards, such as ISO 13485, IEC 60601, and FDA requirements.
- Lead internal and external audits, maintaining thorough documentation and ensuring regulatory readiness.
- Develop and enforce standard operating procedures (SOPs) to ensure consistency and quality in calibration practices.
Team Management and Development:
- Supervise and mentor a team of calibration engineers and technicians, fostering skill development and professional growth.
- Conduct performance evaluations, identify training needs, and implement development programs for team members.
- Delegate tasks effectively, ensuring timely and high-quality completion of calibration activities.
Project Management:
- Plan and oversee large-scale calibration projects, ensuring timelines, budgets, and deliverables are met.
- Coordinate with cross-functional teams, including clinical staff and facilities management, to support operational needs.
- Report project progress, risks, and outcomes to senior leadership and stakeholders.
Innovation and Process Improvement:
- Drive innovation by researching and adopting emerging calibration technologies and tools.
- Identify opportunities to streamline workflows, reduce costs, and enhance calibration accuracy.
- Implement predictive maintenance practices to improve device reliability and operational efficiency.
Stakeholder Engagement:
- Act as a liaison between internal teams, vendors, and regulatory bodies to address technical challenges and maintain compliance.
- Communicate calibration program outcomes, compliance updates, and performance metrics to hospital leadership.
- Address operational challenges and propose innovative solutions to improve system reliability and efficiency.
Skills and Knowledge Required:
- In-depth understanding of biomedical device calibration, maintenance, and troubleshooting.
- Expertise in regulatory standards, such as ISO 13485, IEC 60601, and FDA requirements.
- Proficiency with advanced diagnostic tools, calibration equipment, and data analysis software.
- Strong project management skills, including resource planning, budgeting, and risk management.
- Leadership and organizational skills to manage teams and complex calibration projects effectively.
- Analytical and problem-solving skills to address high-level technical challenges.
Educational Qualifications:
- Bachelor’s or Master’s degree in Biomedical Engineering, Electronics Engineering, Instrumentation, or a related technical field.
- Advanced certifications in project management (e.g., PMP), quality management (e.g., ISO 13485), or calibration techniques are highly desirable.
Key Focus Areas:
Medical Device Control Systems
- Managing calibration processes for advanced medical device control systems to ensure precision and reliability.
Patient Monitoring Equipment
- Overseeing the calibration and maintenance of patient monitoring equipment, ensuring accurate and consistent operation.
Regulatory Compliance (FDA, ISO Standards)
- Ensuring all calibration activities align with FDA, ISO, and other regulatory standards, and leading compliance audits.
Calibration and Maintenance of Medical Equipment
- Strategizing and overseeing the calibration and preventive maintenance of a wide range of medical equipment to ensure optimal performance.
Experience:
- 10+ years of experience in biomedical device calibration and maintenance, with at least 3-5 years in a managerial or leadership role.
- Proven ability to manage large-scale calibration operations and lead multidisciplinary teams.
Tools and Technologies:
- Expertise in advanced calibration tools, including signal simulators, flow analyzers, and electrical safety testers.
- Familiarity with calibration management software and predictive maintenance technologies.
- Knowledge of data analysis platforms for performance monitoring and reporting.
Other Requirements:
- Exceptional communication and interpersonal skills for managing teams and engaging with stakeholders.
- Ability to prioritize and multitask in a dynamic healthcare environment.
- Willingness to travel occasionally for audits, training, or multi-site operations.
- Commitment to maintaining safety, quality, and compliance in all calibration-related activities.