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About the Role

Serve as a senior technical leader guiding the design, development, and lifecycle management of diagnostic and monitoring medical devices, ensuring adherence to technical and regulatory standards. Act as a key technical point of contact, collaborating with customers and leading cross-functional engineering teams to deliver high-quality product engineering solutions.

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

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.
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.
Native level Japanese or JLPT N2 and above, with strong communication, reading, writing, and presentation skills.
Business-level proficiency in English in speaking, reading, and writing.

Skills

Hardware architecture
System engineering
Product development
Schematic design tools (Cadence Allegro, Mentor Graphics, Zuken, Altium)
Component selection
DC-DC converters
Low-voltage signal conditioning circuits
Transducer interface design
Component tolerance analysis
8/16/32-bit processor-based architectures
Memory interfaces (SDRAM, Flash)
Hardware specifications
Test procedures
Board bring-up
Product testing
EMI/EMC compliance testing
Testing equipment (oscilloscopes, multimeters, programmable test loads)
System engineering
Technical leadership
Customer-facing communication
Medical device industry
Diagnostic equipment
Monitoring equipment
Renal devices
Dialysis systems
IEC 60601-1
Medical device product development lifecycle processes
Product Information Management (PIM)
Product Lifecycle Management (PLM)
Japanese language
English language

About the Company

A leading Japanese medical device manufacturer operating through a global engineering organization.