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 recent 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.