TAEJOON®

Position Overview: We are looking for a Biomedical Devices Design & Development Specialist with hands-on experience in developing and optimizing diagnostic imaging systems, particularly X-ray and ultrasound devices. You will play a key role in the design, prototyping, regulatory strategy, and deployment of next-generation diagnostic tools. Your work will directly impact how healthcare is delivered in low-resource and remote environments. Key Responsibilities: Design & Development: Lead the design and development of biomedical imaging devices, focusing on X-ray and ultrasound platforms. Prototyping: Rapidly prototype hardware solutions and iterate based on testing and clinical feedback. System Integration: Collaborate with software and data teams to integrate imaging hardware with AI/ML solutions, cloud platforms, and EHR systems. Clinical Validation: Work closely with radiologists and pathologists to define device specifications, test protocols, and user workflows. Regulatory & Compliance: Support documentation for regulatory approvals (e.g., CE, FDA 510(k)) and ensure compliance with safety standards (e.g., IEC 60601). Cross-functional Collaboration: Coordinate with electronics engineers, industrial designers, and manufacturing partners to bring devices from concept to production. Qualifications: Required: Master's or PhD in Biomedical Engineering, Electrical Engineering, Medical Physics, or related field. 5+ years of experience in medical device development with a focus on radiological and/or pathological imaging systems. Deep technical knowledge of X-ray imaging systems (including digital radiography, image acquisition, and shielding). Experience with ultrasound device design, transducer technology, signal processing, and system architecture. Familiarity with image processing, DICOM, and PACS systems. Understanding of medical device safety, EMI/EMC compliance, and relevant ISO/IEC standards. Preferred: Experience in point-of-care or portable imaging solutions. Knowledge of AI in medical imaging and integrating software algorithms with hardware devices. Exposure to low-cost or frugal engineering principles for resource-constrained environments. Prior work with regulatory submissions (FDA, CE) and QMS (ISO 13485).