Job Details

• Product design & development of mechanical components & system.
• Strong understanding of Engineering change management, including identification of problem, finding design solutions, execute change through creation & approval of change orders/notice.
• Derive or remediation of product specifications (performance, reliability, etc.), and their traceability with user needs.
• Conduct engineering analysis, verification and validation activities, write testing protocol and test reports.
• Creation or remediation of technical documents including DHF-Design History File & DMR -Device Master Records -documents, drawings, labeling, instruction for use, technical reports, etc.
• Drive regulatory-driven projects such as EU MDR, UDI, etc.
• Timely and quality deliverables for the assigned project.
• Interact or indulge in technical discussions with the stakeholders (including SMEs, vendors, etc.) globally in product engineering team.
• Execution of NC CAPA implement design controls & risk controls.
• Preparing/ update technical documentation viz. specifications, drawings, engineering analysis, labeling etc.

• Knowledge of engineering change process, and change control procedures.
• Prior sound experience in plastic injection molding, films, and coating is preferred.
• Prior experience in regulatory-driven projects such as EU MDR, UDI is preferred.
• Good working knowledge of CAD Tools: Creo (preferred) / SolidWorks / NX-Unigraphics
• Sound knowledge of drafting standards, GD&T application and Tolerance stack-up analysis.
• Experience on medical device design control process and various development phases, product life-cycle.
• Good knowledge of medical regulations related to quality management system and risk management such as ISO 13485, ISO 14971, 21 CFR 820.
• Competency in statistics, process capability, design of experiment, including statistical applications such as Minitab, etc.
• Problem-solving skills with use of known tools.
• Experience on design & development and manufacturing process of plastic molded components.
• Ability to take technical decision considering requirements.
• Knowledge of material selection basis on their properties (mechanical, chemical, etc.)
• Understanding of NC/CAPA Process, design control & risk management.
• Understanding of inspection process, metrology, and design of jigs and fixtures.

Reference ID - GH/PHL/JC//25102019//87355/Design Engineer - Mechanical