R&D Mechanical Engineer
VAPOTHERM, INC.•Cincinnati, OH
5h
About The Position
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.
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
- Ability to lift 40 lbs of weight
Nice To Haves
- 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
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
