Mechanical Engineer

<b>Key Responsibilities:</b><br /> <br /> Design & Development<br /> Lead end-to-end mechanical design of electro mechanical medical device components<br /> and sub-assemblies from concept through production release.<br /> Develop detailed 3D CAD models and 2D drawings using SolidWorks, including<br /> complex surface modelling for ergonomic and aesthetic design features.<br /> Apply Geometric Dimensioning & Tolerancing (GD&T) principles to ensure design<br /> intent, fit, and manufacturability.<br /> Perform tolerance analysis and mechanical calculations to validate design robustness.<br /> Select materials and manufacturing processes (injection moulding, machining, casting,<br /> sheet metal, etc.) suitable for medical applications.<br /> Support engineering builds and hands-on mechanical testing to evaluate design<br /> functionality, performance, and reliability.<br /> Participate in design brainstorming, feasibility studies, and FMEA sessions to identify<br /> and mitigate risks early in the design cycle.<br /> Collaborate closely with suppliers, toolmakers, and contract manufacturers to ensure<br /> design feasibility, cost-effectiveness, and manufacturability.<br /> Review supplier drawings, tooling concepts, and first article inspection (FAI) reports.<br /> Drive Design for Manufacturability (DFM) and Design for Assembly (DFA)<br /> improvements throughout the development process.<br /> Generate and maintain engineering documentation, including BOMs, drawings, ECOs,<br /> and test reports, in compliance with ISO 13485 and FDA 21 CFR Part 820 design<br /> control requirements.<br /> Cross-functional Collaboration<br /> Work closely with electrical, software, and systems engineers to ensure seamless<br /> mechanical integration.<br /> Coordinate with quality, regulatory, and manufacturing engineering teams<br /> throughout the product lifecycle.<br /> Mentor junior engineers and contribute to best practices in design methodologies<br /> and documentation.<br /> <b>Qualifications & Skills:</b><br /> <b>Education</b>:<br /> Bachelor's or Master's degree in Mechanical Engineering, or related field from<br /> reputed institutes (IIT, NIT,.. etc.)<br /> Experience:<br /> Successfully worked as design engineer and was involved in the design of at least<br /> one medical device during entire cycle of concept to production<br /> Expert-level proficiency in SolidWorks is a must, including surface and solid<br /> modelling of complex geometries.<br /> Strong understanding and practical application of GD&T (ASME Y14.5) and tolerance<br /> stack-up analysis.<br /> Expert-level proficiency in Design for Manufacturability (DFM) and Design for<br /> Assembly (DFA) is a must<br /> Experience in plastic injection moulding, die casting, machined components, and<br /> sheet metal design.<br /> Hands-on experience in prototype testing, fixture development, and test data<br /> analysis.<br /> Knowledge of medical device design control, risk management, and regulatory<br /> standards (ISO 13485, FDA QSR).<br />