Job Title: Biomedical Engineer (Instrumentation)

Job Summary:

The Mid-Level Biomedical Engineer (Instrumentation) is responsible for managing the maintenance, calibration, and optimization of biomedical devices and systems. This role involves handling complex troubleshooting tasks, leading device integration projects, and ensuring compliance with healthcare standards such as FDA and ISO 13485. The engineer provides technical support, mentors junior team members, and collaborates with healthcare professionals to ensure medical devices operate reliably and meet clinical needs.

Key Responsibilities:

Device Maintenance and Calibration:

• Perform advanced calibration, testing, and preventive maintenance for biomedical devices, including imaging systems, ventilators, infusion pumps, and patient monitors.
• Develop and implement preventive maintenance schedules to minimize device downtime and extend equipment lifespan.
• Maintain detailed service logs and ensure compliance with documentation requirements.

Troubleshooting and Diagnostics:

• Diagnose and resolve complex technical issues in biomedical devices using advanced diagnostic tools and methodologies.
• Conduct root cause analyses for recurring device malfunctions and implement corrective actions.
• Collaborate with vendors, manufacturers, and cross-functional teams to address critical device challenges.

Device Integration and Upgrades:

• Lead the installation, configuration, and integration of new biomedical devices into healthcare systems.
• Validate and test system compatibility and functionality after installations or upgrades.
• Support retrofitting projects to align older systems with current healthcare technologies and standards.

Regulatory Compliance and Quality Assurance:

• Ensure all operations comply with FDA, ISO 13485, IEC 60601, and other healthcare standards.
• Participate in internal and external audits and contribute to maintaining quality certifications.
• Refine and enforce standard operating procedures (SOPs) for device maintenance and quality assurance.

Collaboration and Support:

• Provide technical guidance and support to clinical teams, ensuring devices meet operational and performance requirements.
• Act as a liaison between clinical staff and technical teams to address device-related concerns.
• Train healthcare staff on the safe and effective use of biomedical devices.

Leadership and Mentorship:

• Mentor junior engineers and technicians, providing guidance on troubleshooting, maintenance, and compliance practices.
• Conduct technical workshops and training sessions to build team proficiency in biomedical instrumentation.
• Supervise routine tasks performed by junior team members to ensure quality and compliance.

Innovation and Process Improvement:

• Identify opportunities to optimize maintenance workflows and device performance.
• Introduce automation tools or advanced technologies to improve operational efficiency.
• Stay updated on emerging trends in biomedical engineering and implement relevant advancements.

Key Focus Areas:

• Device Reliability: Ensure the accuracy, reliability, and performance of biomedical devices.
• Advanced Troubleshooting: Resolve complex issues and implement long-term corrective actions.
• Leadership: Mentor junior staff and lead device integration and maintenance projects.
• Compliance: Ensure strict adherence to healthcare standards and regulatory requirements.

Skills and Knowledge Required:

• In-depth knowledge of biomedical devices, including imaging systems, patient monitors, ventilators, and laboratory equipment.
• Strong troubleshooting skills and familiarity with diagnostic tools such as signal simulators, electrical safety analyzers, and flow meters.
• Proficiency in healthcare regulations and standards (e.g., FDA, ISO 13485, IEC 60601).
• Effective communication and leadership skills for managing teams and collaborating with stakeholders.
• Analytical skills for data interpretation and identifying areas for process improvement.

Educational Qualifications:

• Bachelor’s degree in Biomedical Engineering, Instrumentation Engineering, Electronics Engineering, or a related technical field.
• Certifications in advanced medical device maintenance or regulatory compliance (e.g., ISO 13485, Lean Six Sigma) are preferred.

Experience:

• 3-5 years of experience in maintaining, troubleshooting, and integrating biomedical devices.
• Proven ability to manage medium-scale projects and mentor junior team members.

Tools and Technologies:

• Proficiency with calibration tools and diagnostic equipment for advanced biomedical devices.
• Familiarity with software tools for logging performance data and ensuring regulatory compliance.
• Exposure to automation and predictive maintenance tools is advantageous.

Other Requirements:

• Strong organizational and multitasking skills to manage multiple priorities effectively.
• Willingness to work in dynamic healthcare environments and adapt to operational demands.
• Commitment to maintaining high standards of safety, quality, and compliance.