Job Description

Industry: Major Japanese medical device manufacturer

Responsibilities

• Design and verification of medical devices

• Molded product design crepe

• Mechanism design fiber

• Creation of design documents

• Design by 3D-CAD(Solidworks)

• Experiments and report writing

• Creation of various forms

Requirements

Must Have

• Hands on experience for three years or more in the above-mentioned service

• Structural design, drive design, exterior design, and mechanical safety design.

Good to Have

• Experience and knowledge of strength analysis and vibration analysis

• Experience in system and risk management engineering as well as design control and change control.

• Proficiency in CAD software (Solidworks, Creo, IDEAS NX, CATIA)

• Generate detailed engineering drawings, specifications, and documentation to support prototype fabrication and manufacturing processes

• Potential design skill with with Plastic, Sheetmetal & Casting Parts

• Experience in Reverse Engineering & Value Engineering programs

• 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 (Good communication and presentation skills required)

· Japanese - Business level / JLPT N3 or above