Chetan Sharma

Projects: HFO Ventilator (Acutronic Medical, Vyaire medical), Catheters (BWI Johnson and Johnsons)

• Leading off-shore team of 5 people, assigning new projects, status updates
• Design verification of High flow Ventilator manifold sub system as per product requirement specification
• Prepared Verification test protocols and reports by doing physical testing in dedicated test facility
  Creating labels in enlable design software and Adobe illustrator and releasing them in PLM system like windchill and cPDM
• Good experience for MDD to MDR labeling remediation activities
• As per QMS 13485 and ISO 15523
• Creating a D-Part and SA-Part drawing and get approval from R&D and QA
• Creating DMR document like L-Spec, M-Spec, and DNECO
• Coordinating with onsite engineer for project requirements and workflow.
• Supported project planning and execution efforts relating to technical documentation and process development.
• Edited technical documentation for clarity and conformity with overall goals, safety guidelines, and regulatory compliance.

Projects: AGSS receiving system, High Flow Oxygen concentrator

• Design and development of Critical Care medical device and looking after all activities from market research till production
• Concept designing using CREO 7.0 and preparing 2D drawings and releasing to production department
• Prepare test specification and perform trials of new product and unconventional process
• Prepare Design History files, Hazard analysis Matrix, Risk management file
• ISO 14971-2019 in practice of risk management
• Coordinating with other departments regarding product research, quality and development activities.

Projects: Electrical Compressor Bypass Valve (eCBV) for Ford, BMTS-BMW, Toyota, GM

• Customer Interaction for Design and development Review
• Patent Study for infringement design solution
• Unique Design and development one of its kind
• Data Management for trials and calculations in MS Excel and represent through PowerPoint Presentations
• Study of design infringement and analyse adequate design solutions
• Technical support to sales and marketing functions to improve understanding and help drive new business
• Successfully utilized Creo 2.0/Creo 6.0 to design Automotive components specially solenoid Valves
• Solenoid Design calculation
• Tolerance Stack-up, material study
• Building prototypes of components, developing test procedures and conducting tests using software packages and physical testing methods
• New Product development and research work on new products
• Assist in responding to RFQ by carrying out technical feasibility
• Design & Development of Turbocharger Electrical Bypass Solenoid valve
• Making Gap list, PPT regarding all the design and concept queries
• Making SAP-BOM, Routing & Process Documents
• All design and process documents for PPAP - DFMEA, PFD, CP, PFMEA, Check sheets etc
• Critical processes like Laser welding and Ultrasonic welding exposure