Design mechanical components, assemblies, and systems for medical devices from concept to production using Creo & SolidWorks. Hands-on experience in
PDM / PLM
(SAP-ECTR) for managing lifecycle of the components, managing
ECO / ECR
(SAP). Build and test prototypes to validate design performance against specifications and ensure safety and reliability. Select appropriate materials by considering factors critical in the medical industry, such as biocompatibility, sterilization compatibility, and cost-effectiveness. (DFM/DFA): Designs are optimized to ensure they can be efficiently produced and assembled, considering manufacturing processes. Using advanced CAD software such as Creo or SolidWorks, create detailed 2D drawings of components and assemblies. Apply Geometric Dimensioning and Tolerancing (GD&T) to communicate design tolerances and specifications precisely for accurate manufacturing. Generate and maintain the BOM, which is a comprehensive list of all raw materials, components, and assemblies needed to manufacture the final product. Organize and maintain a comprehensive Design History File (DHF), which documents the entire design process, including inputs, outputs, verification, and validation records. Revising and updating technical drawings and documentation as needed and for managing the engineering change order (ECO) process. Ensuring all design and documentation adheres to strict medical device regulations from bodies like the FDA and standards like
ISO 13485.
Work with a range of professionals, including quality assurance, regulatory affairs, manufacturing and sourcing, to bring a product from concept to launch.
Title:
Senior Mechanical Design Engineer(8+ Years)
JD:
Lead mechanical subsystem development from concept and requirements through detailed design, prototyping, testing, and release Strong hands-on experience with 3D CAD, engineering drawings, GD&T, tolerance stack-up, material selection, and DFM/DFA. Experience designing mechanisms, precision assemblies, structures, enclosures, motion systems, or electromechanical products. Apply engineering analysis for structural, thermal, vibration, fatigue, and reliability considerations as applicable. Translate product/system requirements into practical and manufacturable mechanical designs. Support system integration and resolve mechanical, electrical, manufacturing, and interface-related issues. Develop engineering test methods and support design verification activities. Select appropriate materials by considering factors critical in the medical industry, such as biocompatibility, sterilization compatibility, and cost-effectiveness. Drive prototype builds, design iterations, testing, troubleshooting, and root-cause analysis. Participate in design reviews, risk analysis/FMEA, Design Controls, V&V, and design transfer activities. Collaborate with Systems, Electrical, Software, Quality, Regulatory, Manufacturing, and suppliers. Experience supporting early-stage product development, rapid prototyping, and technology maturation is preferred
Pay:
Up to $55.00 per hour Expected hours: 40.0 per week
