System Architect (MedTech)

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.