Job Title: Medical Instrumentation Engineer

Job Summary:

The Senior Medical Instrumentation Engineer is responsible for leading the maintenance, calibration, and optimization of complex medical devices and systems in healthcare environments. This role involves managing large-scale projects, ensuring compliance with regulatory standards, and mentoring junior team members. The senior engineer acts as a technical expert, providing advanced troubleshooting, driving innovation, and collaborating with cross-functional teams to enhance device reliability and support patient care.

Key Responsibilities:

Advanced Maintenance and Calibration:

• Lead calibration, testing, and maintenance of advanced medical devices such as imaging systems, ventilators, patient monitors, and infusion pumps.
• Oversee the development and implementation of preventive maintenance strategies to minimize downtime and extend device life cycles.
• Ensure high accuracy and reliability of medical devices by applying advanced calibration techniques.

Troubleshooting and Diagnostics:

• Diagnose and resolve complex technical issues in medical devices using advanced diagnostic tools and methodologies.
• Conduct root cause analysis for recurring or critical faults and implement long-term corrective actions.
• Collaborate with vendors and manufacturers to address highly specialized technical challenges.

System Integration and Upgrades:

• Manage the installation, configuration, and commissioning of new medical devices and systems.
• Validate and approve system modifications and upgrades to ensure compliance with operational and regulatory standards.
• Lead retrofitting projects to align legacy devices with current technologies and healthcare requirements.

Regulatory Compliance and Quality Assurance:

• Ensure all activities comply with regulatory standards, such as FDA, ISO 13485, and other healthcare regulations.
• Participate in and lead internal and external audits to maintain quality assurance certifications.
• Develop and refine standard operating procedures (SOPs) for maintenance and quality assurance processes.

Leadership and Mentorship:

• Provide technical leadership and mentorship to junior and mid-level engineers, fostering skill development and knowledge sharing.
• Conduct training sessions on advanced medical device technologies and regulatory standards.
• Act as a subject matter expert in medical instrumentation, guiding the team on complex projects and challenges.

Collaboration and Project Management:

• Collaborate with clinical teams, operations staff, and other stakeholders to ensure device performance meets patient care needs.
• Manage large-scale projects, including planning, resource allocation, and reporting progress to senior management.
• Act as a liaison with regulatory authorities, vendors, and internal teams for device-related initiatives.

Innovation and Continuous Improvement:

• Drive innovation by identifying and implementing emerging technologies in medical instrumentation.
• Lead initiatives to automate calibration processes and improve device performance metrics.
• Contribute to research and development projects aimed at enhancing healthcare delivery through advanced instrumentation.

Key Focus Areas:

• Advanced Troubleshooting: Resolve complex technical challenges in medical devices and systems.
• Compliance Leadership: Ensure strict adherence to regulatory standards and quality management systems.
• Team Leadership: Mentor junior staff and guide teams on technical and operational challenges.
• Project Execution: Oversee large-scale projects, ensuring timely and cost-effective delivery.

Skills and Knowledge Required:

• Expertise in advanced medical devices, including imaging systems, patient monitors, and ventilators.
• Strong knowledge of regulatory compliance standards (e.g., FDA, ISO 13485) and risk management processes.
• Advanced troubleshooting skills and familiarity with diagnostic tools and software.
• Proficiency in project management, including resource planning, budgeting, and reporting.
• Excellent leadership and communication skills for mentoring teams and collaborating with stakeholders.

Educational Qualifications:

• Bachelor’s or Master’s degree in Biomedical Engineering, Instrumentation Engineering, Electronics Engineering, or a related technical field.
• Advanced certifications in medical device maintenance, quality management, or regulatory compliance (e.g., ISO 13485, FDA QSR, Lean Six Sigma) are highly desirable.

Experience:

• 7-10 years of experience in medical instrumentation roles, including managing complex devices and leading teams.
• Proven track record of driving operational improvements and successfully completing large-scale projects.

Tools and Technologies:

• Expertise in advanced diagnostic tools, calibration equipment, and software for medical devices.
• Proficiency in data analysis tools (e.g., Minitab, MATLAB) for performance monitoring and quality assurance.
• Familiarity with automation technologies and predictive maintenance tools.

Other Requirements:

• Strong decision-making skills to handle high-pressure situations effectively.
• Ability to manage multiple priorities and align technical operations with organizational objectives.
• Willingness to travel occasionally for on-site support and project management.
• Commitment to maintaining the highest standards of safety, quality, and compliance.