Hardware Design Specialist

Job Description: We are seeking a Senior Technical Lead to lead the hardware design and system architecture of medical devices. You will be responsible for requirements definition, circuit design, test execution, and project management throughout the product development lifecycle, from the conceptual stage to product deployment, to ensure the development of high-quality medical devices. Main responsibilities: * System Design: Defining system-level requirements, creating block diagrams and schematics. * Test Management: Creating test cases and executing tests based on an understanding of the overall system. * Parts Management: Selecting components and scrubbing the BOM (Bill of Materials). * Documentation: Creating hardware design documents, hardware requirements specifications, and related technical documents. * Project Management: Executing project management activities and change management. Job Requirements: [Required (MUST)] * 8+ years of hardware design experience (microcontroller/processor, power solutions, PCB layout, and Gerber data review) * Circuit design: Experience in designing and simulating analog, digital, and mixed-signal circuits. * Development process: Practical experience in the product development lifecycle, from concept to deployment. * Project management: Practical experience in project management. * Industry knowledge: Knowledge of change management, MQMS (Medical Quality Management System), and the medical device industry. * Excellent analytical skills, problem-solving abilities, and attention to detail. * Knowledge of I2C, SPI, serial (RS-232/485), etc. [Preferred (WANT)] * Knowledge of IEC 60601 (safety standard) and EMC testing. * Experience using PLM (Product Lifecycle Management) tools. Language Requirements: * English Level: Business Conversation Level (TOEIC 735-860) * Japanese Level: Business Level(JLPT Level 2 or N2)