Mechanical Designer

Vapotherm; Cincinnati (OH); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading medical device company in Cincinnati is looking for a Mechanical Design Engineer to support new product development and sustaining engineering. This role involves developing mechanical part design, creating solid models and detailed drawings using SolidWorks, and conducting prototyping activities. The ideal candidate will have at least 5 years of mechanical design experience in a regulatory environment. Excellent knowledge of FDA and ISO requirements for medical devices is preferred. Competitive salary and benefits are offered.

Qualifications

• Minimum 5 years of experience in mechanical designing in a regulatory environment.
• Proficiency in SolidWorks surfacing, solid modeling & assembly.
• Experience with machine shop equipment for producing prototype parts.

Responsibilities

• Develops mechanical part design (plastic and metal).
• Conducts tolerance analysis of components and assemblies.
• Provides technical guidance in vendor selection.

Skills

Mechanical design

SolidWorks CAD systems

Prototyping

GD&T practices

Tools

SolidWorks

Job description

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