George Mcgarrity Email Address

Senior Project Manager

Vapotherm develops solutions for respiratory airway therapies.

Summary of Position: Mechanical Designer/ Engineer responsible for mechanical design support for new product development and sustaining engineering. This role provides leadership and 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: Project Management and technical leadership in mechanical design. Mechanical part design (Plastic and metal) Injection mold part design & tooling (Design Transfer) Develop solid model with Pro-E CAD systems Develop print/ purchase specifications and acceptance criteria Conduct tolerance analysis of components and assemblies Provide technical guidance in vendor selection Formulate verification & validation plans; Develop protocols Develop and process engineering change orders (ECOs) Technical expertise in design reviews Support design and process FMEAs Conduct failure investigations on component failures and NCMRs Support vendor selection and supplier audit in areas of expertise (Injection Molding) Assist mold suppliers with manufacturing process validation and troubleshooting Coordinate and lead technical resources assigned to the programs  Participates in the evaluation and selection of new technologies and vendors Knowledge of Quality systems, ISO 13485 and FDA QSR for Medical Devices 3D CAD Expertise (PRO-E and Solid Works) Injection Mold Part Design & Tooling Respiratory System Training 22+ years of experience in medical device and disposable industry Injection Mold part design; Robotic assemblies and processes; Supplier Management Certificates: 3D CAD design (Pro-E); Dukane Sonic weld; Leak Detection; Lean Manufacturing - Experience with CNC, Machining & Production Assembly 6 US patents Associates in Applied Sciences in Plastic Technologies, Morrisville State University