Key Responsibilities:
Field Service & Maintenance: Install, calibrate, and maintain medical devices, diagnostic instruments, and life science equipment at customer sites. Perform regular preventive maintenance (PM) and emergency repairs to ensure the highest operational standards. Diagnose and troubleshoot complex technical issues related to hardware, software, and system performance. Conduct on-site training for customers on proper equipment use and maintenance procedures. Ensure all repairs and services meet industry regulations and compliance standards (e.g., FDA, ISO, CE, Part11, CSV). Customer and Dealer Relationship Management: Establish and maintain strong relationships with customers, understanding their specific needs and providing tailored support. Communicate clearly and professionally with customers to understand issues, provide updates, and offer solutions. Act as a trusted advisor and provide expert guidance on best practices for equipment utilization and maintenance. Self-Management: Communicate with RSM, manage your own schedule Documentation & Reporting: Accurately document service calls, maintenance reports, and equipment issues using the company's service management system. Prepare and submit service reports, detailing the work performed, parts used, and recommendations for future maintenance. Maintain accurate records of customer interactions, service history, and equipment performance. Contact support team by email or MS Teams Chat in English Regular meeting with support team in English Technical Support & Collaboration: Provide remote and on-site technical support to customers, including troubleshooting, software upgrades, and calibration. Collaborate with engineering teams to relay feedback on equipment performance and suggest improvements or updates. Stay current with product updates, technical manuals, and industry trends in medical devices, diagnostics, and life sciencesCompliance & Quality Control: Ensure all service work is performed in compliance with internal and external quality and regulatory standards (e.g., PMDA, FDA regulations, Good Manufacturing Practices, etc.). Follow strict safety protocols and ensure the safe operation of equipment both on-site and during transportation. Qualifications: Education: Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related field, or equivalent work experience. Experience: Minimum of 3 years of experience as a Field Service Engineer working with medical devices, diagnostic instruments, or life science equipment. Demonstrated experience in troubleshooting, servicing, and maintaining complex electro-mechanical systems. Prior exposure to regulated industries (e.g., FDA, ISO, CE) and understanding of compliance requirements. Skills & Competencies: Strong technical troubleshooting and problem-solving skills. Experience with calibration and preventive maintenance procedures. Proficient in the use of diagnostic tools, service management software, and technical manuals. Excellent communication and interpersonal skills, with a customer-focused mindset. Ability to work independently and manage time effectively in a field-based role. Valid driver’s license and ability to travel to customer locations as required. Able to fully utilize the MS Office (Excel/Word/PPT) Excellent communication skills, both verbal and written in English and Japanese Certifications (Optional but preferred): Chief Engineer for Maintenance of Medical Equipment Certification in biomedical or clinical engineering (CBET or similar). Manufacturer-specific certifications or training. Additional Information: Travel Requirements: The role involves frequent travel to customer sites, including potential overnight stays. Work Environment: The Field Service Engineer will work in various environments, including clinical settings, laboratories, hospitals, and research facilities.
