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:

• 3+ years of experience in medical device design
• Experience creating design output/DHFs in accordance with ISO 13485
• Work experience with Mechanical part development, CAD drawings & Manufacturing Drawing
• Experience in Sustenance activities in medical products/ Healthcare business
• Good knowledge on ISO 13485 QMS, IEC Standards (General Safety, Particular & Collateral) and MDR
• Ability to take initiatives and drive the project to completion.

Good to Have

• 3+ years of experience in disposable medical device design

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

Job Tags

Similar Jobs