• Actively participating in the complete product design cycle, collaborating with cross-functional teams to refine concepts and meet project milestones.• 2 years of professional experience in the Medical Device Development domain, involved in New Product Development and Sustaining Engineering.• Part of the core team for Thulium Fiber Laser System Design, a Class 4 laser product.• Hands-on experience in Software System and Unit Integration Testing to ensure functional and performance requirements are met.• Expertise in 3D Modeling: Proficient in using SolidWorks, AutoCAD, CATIA, NX, and Creo to create accurate and detailed 3D models, ensuring adherence to industry standards.• Proficient in creating Design History File (DHF) documents and conducting risk analysis, including DFMEA, PFMEA, and UFMEA.• Conducting benchmarking studies to integrate industry trends and best practices into the design process.• Experienced in performing tolerance stack-up analysis and knowledge of GD&T, ensuring design feasibility and product functionality.• Hands-on experience with 3D Printing, Reverse Engineering for legacy parts, and Topology Optimization.• Knowledge of Design Controls, Validation processes, and Biocompatibility for medical device standards (ISO 13485, IEC 60825, IEC 60601, IEC 62304, ISO 14971).• Knowledge of manufacturing processes such as Injection Molding, Additive Manufacturing, and Machining Processes.• Experience in process verification, change management (ECR, ECO, ECN), and regulatory compliance according to medical device standards.• Skills: Product Design and Development, Sustaining Engineering, Risk Analysis (DFMEA, PFMEA, UFMEA), Benchmarking and Best Practices Integration, CAD Modeling (SolidWorks, AutoCAD, CATIA, NX, Creo), Tolerance Stack-Up Analysis, Design Controls and Compliance, 3D Printing and Reverse Engineering, Knowledge of Medical Device Standards (ISO 13485, IEC 60825, IEC 60601, IEC 62304, ISO 14971), Manufacturing Processes (Injection Molding, Additive Manufacturing, Machining).• Tools Used: SolidWorks, AutoCAD, ANSYS, CATIA, NX, Creo, MS Office.
