Mechanical Design Engineer

Job Description

We are seeking a hands-on Mechanical Design Engineer with strong design thinking and experience in medical devices to support the development of both new products and improvements to existing devices . The ideal candidate will work closely with cross-functional teams to ensure high-quality, regulatory-compliant designs, and support design transfer , vendor communication, and ISO 13485 documentation. Key Responsibilities: Lead mechanical design efforts for new medical devices and design updates to existing products. Create detailed 3D CAD models, assemblies, and 2D manufacturing drawings using tools such as: Autodesk Inventor / Fusion 360 Creo or equivalent Conduct and interpret mold flow simulations and DFM (Design for Manufacturing) for injection-molded and machined parts. Ensure compliance with ISO 13485 design control processes including: Risk management (ISO 14971) Design History File (DHF) Traceability matrix, design input/output documentation Support design transfer activities to manufacturing, ensuring all specifications and documentation are complete and validated. Manage design changes systematically via ECOs (Engineering Change Orders) and update relevant documentation. Collaborate with vendors, tooling partners, and manufacturing teams to align on feasibility, materials, tolerances, and timelines. Ensure timely delivery of design milestones while maintaining high quality and attention to detail. Support prototype development and hands-on testing and iteration. Qualifications: Bachelor’s or Master’s degree in Mechanical Engineering or related field. 1+ years of experience in mechanical design, preferably in the medical device industry . Strong working knowledge of CAD software and design simulation tools . Understanding of plastics, injection molding, and part tolerancing for high-precision components. Familiarity with ISO 13485 , FDA design controls , and related quality systems. Excellent problem-solving , design thinking , and technical communication skills. Ability to work hands-on with prototypes and collaborate in a fast-paced R&D environment. Nice to Have: Experience with GD&T , FMEA , and root cause analysis Knowledge of rapid prototyping , 3D printing, and assembly processes Familiarity with PLM tools (e.g., Arena, Agile) Job Type: Full-time Pay: Up to ₹30,000.00 per month Benefits: Provident Fund Ability to commute/relocate: Siruseri, Chennai, Tamil Nadu: Reliably commute or planning to relocate before starting work (Required) Work Location: In person