Mechanical Engineer

Job Description

Appealing Points:

• Core Role in Medical Device Development: Contribute directly to the design and verification of safe, high-quality medical devices in compliance with ISO 13485 and IEC standards.
• Hands-On Design Expertise: Engage in end-to-end design activities—from 3D-CAD modeling to experimentation and documentation—leveraging your technical and creative skills.
• Opportunity to Work to Global Quality Standards: Gain experience in design documentation, DHF creation, and compliance with international regulations such as ISO 13485 and MDR, enhancing your global engineering profile.

Annual Salary: 5 Million yen and above

Job Description:

• Design Change Procedures
• Design and verification of plastic medical devices
• Creation of design documents
• Design using 3D-CAD
• 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.

Preferred Qualifications:

•   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.