Mechanical Design Engineer -Medical Device

Job Description We are seeking a Mechanical Design Engineer to join our medical device development team. The ideal candidate will have hands-on experience designing plastic injection molded parts, sheet metal components, and precision machined parts. You will be responsible for end-to-end product design including concept development, 3D CAD modeling in SolidWorks, design validation through calculations and simulation, and collaboration with cross-functional teams for prototyping and production. Roles & Responsibilities Demonstrated proficiency in the following areas: • Lead concept generation and feasibility studies for new mechanical designs in line with product requirements and regulatory constraints. • Develop detailed 3D CAD models, 2D manufacturing drawings, and BOMs using SolidWorks, applying GD&T and best practices for documentation. • Perform design calculations to validate mechanical strength, fit/function, and performance under load, pressure, or thermal conditions. • Conduct tolerance analysis and stack-up studies to ensure robustness and manufacturability of assemblies. • Design for manufacturability (DFM), assembly (DFA), and cost optimization, particularly for plastic injection molded, sheet metal, and precision machined parts. • Select and specify COTS (Commercial-Off-The-Shelf) components based on performance, regulatory, and lifecycle criteria. • Collaborate closely with toolmakers, mold designers, and manufacturing vendors to ensure feasibility, tooling readiness, and part quality. • Prepare and maintain all relevant Design History File (DHF) documentation including design inputs, outputs, V&V protocols, and reports. • Contribute to risk management activities, including FMEA, hazard analysis, and traceability of risk controls. • Support the development of test fixtures, oversee prototyping, and participate in design verification and validation testing. • Participate in cross-functional design reviews, integrating feedback from regulatory, quality, manufacturing, and user experience teams.. Read and understand the provided Design Inputs and Design requirements with minimal supervision.