Mechanical Design Engineer (NPD + Sustenance)

Job description

**Role : Deputy Manager - Mechanical Design Engineering - NPD + Sustenance Engineering** Location : Bengaluru, India The Mechanical Design Engineer is responsible for supporting the design & qualification of new and existing products. **Role in a nutshell:** - Support multiple projects that are ranging from new product development to life cycle management/ sustaining engineering. - Support in design requirements and development of specifications based on user requirements. - Contributes to development and documentation of mechanical system architectures. - Contributes in 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. - Support internal and external inspections/ regulatory audits. - Promote continuous improvement in design control activities and use of quality tools with design team. - Knowledge and understanding of 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, 21 CFR 4 Regulation of Combination Products, 14971 Risk Management Standard. - Exposure to complaint investigation, corrective action and preventive action system, statistical methods, quality risk management and Post Market Surveillance. - Provide input 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. - Creates and develops designs of mechanical assemblies, mechanisms, and component parts for electro-mechanical medical devices meeting set requirements. - Must be able to participate in design reviews for reviewing the design changes & seek management approval to move forward. **Qualifications and Skills:** - A graduate or a postgraduate in Mechanical or related engineering and 4-6 years related experience. Exposure to medical device lifecycle management preferred. - 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.