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engineeringjobs.net, Inc. is seeking a skilled Mechanical Engineer to design, develop, and sustain mechanical components for medical devices. You will drive life cycle activities, document changes, and support testing, risk management, and manufacturing processes.
The role requires a B.S. in Mechanical Engineering and 4–7 years of relevant experience, including injection-molded component design. Familiarity with design controls, regulatory standards, and CAD tools like SolidWorks is preferred.
Design, develop, and sustain mechanical components and sterile consumables for medical devices, including material selection, reliability analysis, and product life cycle support. Manage development and design changes from concept through launch, including documentation, testing, risk management, manufacturing support, and regulatory audit participation.
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 proficiency, reliability testing, project management, and knowledge of design controls and applicable regulatory standards are preferred.
Key Skills: Mechanical Design, Injection-Molded Component Design, Material Selection, Reliability Testing, Product Development, Life Cycle Engineering, Design Controls, Verification and Validation, Risk Management, FMEA, Project Management, CAD, SolidWorks, Manufacturing Collaboration, Regulatory Compliance