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

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