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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