Senior Mechanical Design Engineer - Medical Devices

Senior Design Engineer Work Flexibility: Hybrid What You Will Do: Design & development of mechanical and electromechanical components & systems in the medical device domain. Working on multiple projects simultaneously in product engineering such as gap assessments, design changes, manufacturing transfers, product development, regulatory or business-driven projects, etc. Derive or remediate design requirements/engineering specifications (including performance, reliability, etc.) that meet the user need requirements. Creation or remediation of Design History Files, Device Master Records and other related technical documents including drawings, labelling, packaging, instruction for use, etc. Driving the engineering changes through proper planning & analysis of change impact, creation of change orders/notices & applicable documents, execution of change for implementation through multiple review processes & coordinating with various stakeholders involved. Experience in executing NPD projects involving complete product development life cycle phases form concept to launch. Engineering analysis through simulation, design of experiments, statistics, engineering calculations, etc. Liaison with lab team to carry out verification and validation activities that include the development of test methods, test protocols, test method validation, test execution, analysis, and reporting. Collaboration with divisional partners to drive the assigned projects within schedule, cost & quality baselines. Involve in technical discussions with the stakeholders (including SMEs, vendors, etc.) globally. Execution of NC CAPA implement design controls & risk controls. What You Need: Required Skills: Master/Bachelor’s in Engineering, Mechanical Engineering. 4-8 years of work experience Strong technical ability in creating engineering drawings and models, and applying GD&T and CAE tools. Experience of working on electromechanical devices and enclosures. Deep understanding of thermal simulations is required. Skilled in interpreting design, analyzing, and doing DFM, DFI, materials and manufacturing. Experience in executing NPD projects involving complete product development life cycle phases form concept to launch Adept at applying knowledge of materials and manufacturing processes to product design. Ability to communicate moderate complexity plans and technical information to team members. Good working knowledge of CAD applications (Creo/SolidWorks/UniGraphics). Strong knowledge of sheet metals and plastic parts design, manufacturing, and testing methods. Understanding of engineering change process with prior experience in creating engineering change notices or orders, conducting design or change reviews and implementing them. Competency in statistics, process capability, design of experiments, including statistical applications such as Minitab, etc. Highly developed problem-solving skills with demonstrated successful resolution of project-level issues. Good understanding of designing of jigs & fixtures and inspection methods. Preferred Skills: Experience with analysis tools, specifically tolerance analysis, CFD and FEA using ANSYS software preferred. Experience of working on cameras or related imaging products is preferred. Experience in working with regulated industries like Medical devices, Aerospace, Automotive etc. Understanding of medical device standards and regulations is preferred. Travel Percentage: 10% Experience Level Senior Level