Mechanical Designer

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.

• Develops mechanical part design (Plastic and metal)
• Develops solid model & detailed 2D drawings with Solid Works CAD systems
• Manages 2D drawings & 3D CAD in Solid Works 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

• Minimum 5 years of experience of mechanical designing in a regulatory environment
• Proficiency in Solid Works 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