Mechanical Engineering - (Associate Manager/ Manager) Role & responsibilities Manage/support multiple projects that are ranging from new product development to life cycle management/ sustaining engineering. Defines design requirements and development specifications based on customer or user requirements. Contributes to development and documentation of mechanical system architectures. Contributes to ideations, troubleshooting and problem solving efforts related to new product development and sustaining projects. Hands-on experience in Design History File compilation / Technical file documentation. Good understanding of 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, 21 CFR 4 Regulation of Combination Products, 14971 Risk Management Standard, MDD, MDR, IEC/EN 62366 Application of Usability Engineering to Medical Devices, and ANSI HE75 Human Factors Engineering in Design of Medical Devices Experience in complaint investigation, corrective action and preventive action system, statistical methods, quality risk management and Post Market Surveillance Creates and develops designs of mechanical assemblies, mechanisms, and component parts for electro-mechanical medical devices meeting set requirements. Performs in-depth mechanical analysis and calculations including kinematic analysis, tolerance analysis, structural analysis- FEA to evaluate design robustness and to ensure consistent performance and safety of critical functions. Ensures successful integration of mechanical design elements with electrical and consumable components. Build and test design concepts and Engineering prototypes for verification. This includes compiling and presenting data to support design verification of new products in accordance with company and regulatory requirements. Lead activities related to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting devices can be adequately manufactured and verified. Must be able to participate in design reviews for reviewing the design changes & seek management approval to move forward. Preferred candidate profile A graduate or a postgraduate in Mechanical or related engineering and having minimum 8 years related experience. Exposure to medical device lifecycle management preferred. Hands on experience in electromechanical product development, preferably medical devices. Knowledge and experience using CAD systems for mechanical design and analysis (Solidworks preferred). Knowledge of standards such as IEC 60601, ANSI and ASTM preferred. Knowledge on Risk assessment, Root cause analysis procedures, DFMEA, PFMEA, ISO, etc is desirable. Knowledge of DFM & DFA with respect to ease of manufacture and assembly. Knowledge of Design and manufacturing Engineering of metal and plastic parts is required. Excellent communication skills- Written and oral such as Technical documentation, Presentation skills.
