Responsible for mechanical design support for new product development and sustaining engineering. This role works closely with other functional leaders in the company to ensure that programs yield the quality, cost and performance objectives on schedule, within budget and in compliance with ISO 13485 and FDA QSR for medical devices.
PRIMARY RESPONSIBILITIES
Develops mechanical part design (Plastic and metal)
Develops solid model & detailed 2D drawings with SolidWorks CAD systems
Manages 2D drawings & 3D CAD in SolidWorks PDM
Develops detail part specifications and prints, purchase specifications and acceptance criteria
Conducts prototyping activities, including part fabrication and assembly.
Conducts tolerance analysis of components and assemblies
Provides technical guidance in vendor selection
POSITION REQUIREMENTS
Minimum 5 years of experience of mechanical designing in a regulatory environment
Proficiency in SolidWorks surfacing, solid modeling & Assembly
Experience with machine shop equipment for producing prototype parts
Experience with Design for Manufacture techniques, including injection molding
Experience with software and tools for mechanical designing
Experience with GD&T designing practices
Understanding of FDA, MDD, and ISO Quality System Requirements (including safety and regulatory testing) and their application within a medical product development environment, a plus
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PRIMARY RESPONSIBILITIES
Develops mechanical part design (Plastic and metal)
Develops solid model & detailed 2D drawings with SolidWorks CAD systems
Manages 2D drawings & 3D CAD in SolidWorks PDM
Develops detail part specifications and prints, purchase specifications and acceptance criteria
Conducts prototyping activities, including part fabrication and assembly.
Conducts tolerance analysis of components and assemblies
Provides technical guidance in vendor selection
POSITION REQUIREMENTS
Minimum 5 years of experience of mechanical designing in a regulatory environment
Proficiency in SolidWorks surfacing, solid modeling & Assembly
Experience with machine shop equipment for producing prototype parts
Experience with Design for Manufacture techniques, including injection molding
Experience with software and tools for mechanical designing
Experience with GD&T designing practices
Understanding of FDA, MDD, and ISO Quality System Requirements (including safety and regulatory testing) and their application within a medical product development environment, a plus
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