R&D Mechanical Designer

SUMMARY 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 injection mold part design(Design Transfer)

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

Provides technical expertise in design reviews

Reviews First Article Inspection Reports & reconcile design conflicts

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

Ability to lift 40 lbs of weight

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