Sr. Consumables Mechanical Engineer

Job Description

Design, develop, and sustain mechanical components and assemblies for medical devices and sterile consumables, including material selection, reliability analysis, and verification and validation. Manage product changes and development documentation, support manufacturing and regulatory audits, and improve product reliability, quality, cost, and production feasibility.

Requirements: A bachelor’s degree in Mechanical Engineering and 4–7 years of relevant mechanical engineering experience are required, including at least 2 years designing injection-molded components. Medical device or sterile product experience, CAD and project management tools, reliability testing, and knowledge of design controls and applicable medical device regulations are preferred.

Key Skills: Mechanical Design, Medical Device Development, Sterile Consumables, Injection-Molded Component Design, Material Selection, Reliability Testing, CAD, SolidWorks, Project Management, Design Controls, Verification and Validation, Risk Analysis, FMEA, Manufacturing Engineering, ISO 13485, FDA 21 CFR 820