Mechanical Design and Development Job at Fidel Consulting KK, 東京都

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  • Fidel Consulting KK
  • 東京都

Job Description

Appealing Points:
  • Engage in the Design and Verification of Medical Devices : Contribute to the development of safe and high-quality medical products through 3D-CAD design (SolidWorks, Creo) and performance testing.
  • Opportunity to Apply Diverse Mechanical Design Skills : Work on plastic, sheet metal, and casting part designs while performing simulations and prototyping to ensure structural integrity and functionality.
  • Gain Global-Standard Engineering Experience : Build expertise in medical device regulations and quality systems such as ISO 13485 and FDA CFR21.820, enhancing your professional value in international markets.

Annual Salary: 5 Million yen and above

Job Description:

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

Job Qualifications:

  • Hands on experience for three years or more in the above-mentioned service
  • Experience in molded product design, experience in mechanical design

Good to Have

  • Generate detailed engineering drawings, specifications, and documentation to support prototype fabrication and manufacturing processes
  • Potential design skill with Plastic, Sheetmetal & Casting Parts
  • Experience in conducting static analysis, Structural Analysis, and vibration analysis simulations using Finite Element Analysis (FEA) tools to assess structural integrity, durability, and performance of mechanical systems and components
  • Knowledge of regulatory standards and compliance requirements for mechanical products and components.
  • Experience in Rapid prototyping for functional prototype development
  • Awareness of 3D Printing
  • Experience with Quality Management Systems and complying with ISO13485 and FDACFR21.820 are preferable
  • Understanding of applicable manufacturing/testing procedures of medical devices and manufacturing processes and familiar with regulations and standards

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, 3D Printing, 3D-CAD , product design, medical device, Engineering

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