Mechanical Designer

About This Role

This role provides mechanical design support for both new product development and sustaining engineering, ensuring programs meet quality, cost, and performance objectives within budget and in compliance with medical device regulations.

Responsibilities

• Develop mechanical part designs (plastic and metal)
• Develop injection mold part designs (Design Transfer)
• Develop solid models and detailed 2D drawings using SolidWorks CAD systems
• Manage 2D drawings and 3D CAD in SolidWorks PDM
• Develop detailed part specifications, prints, purchase specifications, and acceptance criteria
• Conduct prototyping activities, including part fabrication and assembly
• Conduct tolerance analysis of components and assemblies
• Provide technical guidance in vendor selection
• Provide technical expertise in design reviews
• Review First Article Inspection Reports and reconcile design conflicts

Requirements

• 5+ years of mechanical designing experience 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
• Ability to lift 40 lbs of weight

Qualifications

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

Nice to Have

• Understanding of FDA, MDD, and ISO Quality System Requirements (including safety and regulatory testing) and their application within a medical product development environment

Skills

* Required skills