Mechanical Engineer – Medical Devices

Role Overview

The Mechanical Engineer will be responsible for the design, development, and improvement of mechanical components and systems

Key Responsibilities

Design and develop mechanical structures, housings, piping, and precision components for medical devices.

Perform structural analysis, tolerance analysis, and reliability assessments.

Support prototype fabrication, testing, and mass‑production transfer.

Collaborate with electrical, software, and manufacturing teams.

Prepare technical documentation in compliance with ISO 13485 and design control requirements.

Support risk management activities (FMEA, DFMEA).

Required Qualifications

Experience in medical devices, precision equipment, or regulated manufacturing environments preferred.

Knowledge of CAD tools (e.g., SolidWorks, CATIA, or equivalent).

Understanding of medical device standards and quality systems is a plus.

Language proficiency: Japanese (N2/N1), English(Business Level Communication) is preferred.