Staff Mechanical Engineer, Durham, North Carolina

Job Description

The Staff Mechanical Engineer will design, develop, and test mechanical components and systems for pharmaceutical equipment using CAD and FEA tools. They will also collaborate with cross-functional teams, conduct mechanical analyses, and manage engineering documentation to ensure regulatory compliance.

Requirements: Candidates must hold a bachelor's degree in Mechanical Engineering and possess over 10 years of experience, ideally in the medical device industry. Proficiency in 3D CAD software like SolidWorks and experience with design controls such as ISO 13485 are required.

Key Skills: Mechanical Engineering, SolidWorks, Finite Element Analysis, CAD, Stress Analysis, Strain Analysis, Thermal Analysis, Product Development, Test Planning, FMEA, Design Control, ISO 13485, FDA QSR, Prototyping, Manufacturing Process Development, Risk Assessment