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Our Mequon area client has an immediate need for a "Direct Hire" Solidworks Design/Drafter.
The Designer/Drafter is responsible to apply knowledge of mechanical drafting and design principles, practices, and procedures to assist the design and development of new or improved medical devices (e.g. instruments and implants).
The Designer/Drafter will assist, under the direction of Product Development Engineers, in the design of new products using the company’s design control procedure. The Designer/Drafter will also be responsible for maintaining compliance to industry and regulatory guidelines and standards when creating documents included in the Design History File.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Carry out drafting and design assignments such as CAD models, assemblies, drawings, and specification documents consistent with industry standards and guidelines (e.g. ANSI 14.5, ISO 9000, ISO 13485), GMP documentation, and common mechanical design practices.
Create part, assembly, sub-assembly, and detail level models and drawings based on concepts and ideas from the Product Development Engineers.
Complete and maintain compliance with document/design control procedures. Participate in Document Change Record forms as means of documenting and controlling changes to product design and specifications.
Completion of additional activities such as checking, Geometric Dimensioning and Tolerancing (GD&T)
Provide insights and recommendations about Design for Manufacturability (DFM) and Design Failure Mode Effects Analysis (dFMEA).
Assist in the development of best practices about the creation of models, assemblies, drawings, and specification documentation.
Participate in the implementation and management of a product data management software (e.g. SolidWorks PDM). Manage CAD data created within the Design Control system.
Qualified candidates may possess an A.S. or B.S. or Technical degree in Design or Drafting, or equivalent experience
Advanced mechanical/mechanism design and drafting capabilities.
Proficient use of with SolidWorks(preferred) or other CAD experience
Proficient in industry standard practices including design and drafting for manufacture. Familiar with ANSI/ASME Y14.5 for GD&T.
Strong Attention to details and ability to take a project from concept to completion.
Experience in a highly regulated environment is desirable, preferably in the medical devices industry.
For immediate consideration, please forward your resume!