The posting
We are hiring a System Architect for a leading Japanese medical device manufacturer through a global engineering organization. As a System Architect for Medical Devices, you will serve as a senior technical leader, guiding the design, development, and lifecycle management of various diagnostic and monitoring medical devices while ensuring adherence to applicable technical and regulatory standards. You will serve as a key technical point of contact, working directly with customers and leading cross-functional engineering teams to deliver high-quality product engineering solutions. Key Responsibilities: Lead hardware architecture, system engineering, and product development activities for medical devices. Drive engineering solutions from customer requirements gathering through product realization. Take ownership of system architecture and product development as a Product Owner / System Architect. Coordinate hardware, software, and mechanical engineering teams, including offshore teams. Oversee hardware design, development, integration, testing, and product lifecycle activities. Ensure compliance with relevant technical and medical device regulatory standards. Work closely with customers to understand their requirements, address technical challenges, and propose solutions. Contribute to proposals and initiatives that expand customer engagement. Requirements Essential Skills: Strong knowledge of product development workflows, particularly hardware design and development. Hands-on experience with schematic design tools such as Cadence Allegro, Mentor Graphics, Zuken, or Altium. Experience in component selection, DC-DC converters, low-voltage signal conditioning circuits, transducer interface design, and component tolerance analysis. Practical experience with 8/16/32-bit processor-based architectures and memory interfaces such as SDRAM and Flash. Experience preparing hardware specifications and test procedures. Hands-on experience with board bring-up, product testing, and EMI/EMC compliance testing. Familiarity with testing equipment such as oscilloscopes, multimeters, and programmable test loads. Strong system engineering, technical leadership, and customer-facing communication skills. Desired Skills: Experience in the medical device industry, particularly diagnostic or monitoring equipment. Experience with renal devices, especially dialysis systems, is highly preferred. Knowledge of medical device standards such as IEC 60601-1. Familiarity with medical device product development lifecycle processes and documentation. Awareness of Product Information Management (PIM) and Product Lifecycle Management (PLM) tools. Language Requirements: Japanese: Native level or JLPT N2 and above, with strong communication, reading, writing, and presentation skills. English: Business-level proficiency in speaking, reading, and writing.
