Job Description

Appealing Points:

• Contribute to the Development of Life-Saving Medical Devices : Engage in the design and verification of plastic medical equipment using 3D-CAD (SolidWorks, Creo), directly supporting improvements in healthcare quality.
• Utilize Comprehensive Mechanical Design Expertise : Apply your experience in injection molding, sheet metal, and casting design while collaborating on manufacturable and high-precision engineering solutions.
• Gain Global Regulatory and Quality System Experience : Build expertise in international medical device standards such as ISO13485, FDA CFR21.820, IEC 60601-1, and MDR 2017/745, enhancing your career in the global medical engineering field.

Annual Salary: 5  Million yen and above

Job Responsibilities:

• Design and verification of plastic medical devices
• Creation of design documents
• Design using 3D-CAD (Solidworks, Creo)
• Experiments and report writing
• Creation of various forms

Job Qualifications:

• Mechanical design engineer with more than three years of experience using 3D-CAD
• Injection molding design experience
• Proficiency in Plastic, Sheetmetal & Casting Parts for medical equipment
• Good knowledge of manufacturing processes

Good to Have

• Generate detailed engineering drawings, specifications, and documentation to support prototype fabrication and manufacturing processes
• Knowledge of 3D Printing
• Experience with Quality Management Systems and complying with ISO13485 and FDACFR21.820 are preferable
• Understand applicable medical device manufacturing/testing procedures and manufacturing processes and be familiar with regulations and standards like IEC 60601-1, MDR 2017/745 or MDR 2017/746

Language Skill:  

• English – Business-level proficiency (conversation, reading, writing, etc.)
• Japanese - Native level, or JLPT N2 or above (Good communication, reading, writing and presentation skills required)

Company Description:

We are a global engineering organization dedicated to building a brighter future. What sets us apart is not just what we do, but why we do it. We believe engineering has the power to solve today’s challenges and pave the way for a better tomorrow. For over 25 years, we’ve been a trusted partner in tackling the world’s toughest engineering problems. Headquartered in Singapore, we operate in 17 countries with 67 global delivery centers and offices, supported by a team of 17,800+ exceptional professionals who make the impossible possible every day.

Job Requirements: Japanese JLPT N2, English 2, 3D-CAD, Mechanical design , engineer , Quality Management System, manufacturing processes, medical device, medical domain

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