• As a Project Manager Co-ordinate with Subject Matter Experts (“SME/s”) & labeling stakeholders for requirements gathering, analysing and lead the review sessions.• Ensure Onsite-Offshore activities and connect clients on regular basis to ensure smooth progress.• Ensure smooth coordination of project activities between Buyer and SME team.• Requirement gathering for each label change & in certain cases, finalize verbiage for the proposed change as per the requirement. • Analyse and Execute graphics changes in Labels per client direction.• Provide Change Management assistance for Change Assessment, Tasks, Route RCH and follow up on approvals • Review the final RCH before routing for proofreading to get approvals.Significant Project:• EU MDR Compliance program

• Change Management support, i.e., Co-ordinate with respective stake holders to sign-off the Labeling Change Request form (LCR), Change Impact Assessment form (CIA), TM & attorney approval form and Supplier Notification form (SNF), Initiate change assessment in PLM, create change order, revise affected documents, Part disposition, action task, implementation task and promote Change orders.• Obsolescence Management - Obsolete the catalog codes that were no longer manufactured or offered for sale from client system and lay down a specific process flow for all similar activities in future.• Concept generation and analyse using 3D modelling Software.• CAD conversion activities of Machines in Solidworks. (3D Models, Detail Drawings, BOM, and DFM)• Presales support – SOW, Preparing Case Study and Process Flow Chart.• PMO Activities - Generating OM reports & Plan, Proposal tracker, Utilization reports, Critical demands. Future release and Bench reports.Significant Projects:• Biopsy forceps - Concept Generation & Prototype development. (RFP)• Acetabular cup impactor - Concept Generation. (RFP)• CAD Model & Drawing Conversion Project (Solid works).• Redbird project - Labeling change management support during the acquisition of Cordis by Cardinal Health – Freemont & Milpitas, CA. (Onsite)• Notified body change project- Due to Brexit, notified body changes from BSI-UK to BSI-Netherlands for Biosense Webster Inc, Irwindale, CA. (Onsite)• GS1/UDI Support (ADAPTIV & enLabel)- Coordinates and provided support on label /template design (enLabel IPM & design tool) during migration. (Offshore). • Gap Analysis Implementation support - Comparison of versions of ISO standards, map all the ERCs to new revisions of the standards, identify potential gaps, prepare & review an implementation checklist.

Structural design and Quality, • Receive the drawings from vendor and convert into 3D model.• Analyze the assembly by prepare Manufacturing drawings and Assembly drawings with exploded views.• Assembled the developed components with the sequential operations.• Prepare Bill of materials. • Monitoring & resolving welding related problems at every stage of assembly.• Training of welders and technicians for special welding procedure to meet international standard.• Involved in preparation of WPS, PQR, WPQR and Fabrication Process Planning of Pressure Vessels, columns.• Materials handled are Carbon Steel and Low Alloy Steels.• Coordinate NDE methods.• Codes and Standards followed AWS and ASME Sec.V, Sec.VIII, Sec.IX.Significant Projects:• Heavy Engineering products in Boiler Accessories• Windmill• Structural Columns - '+' Columns, Box Columns, 'I' Columns• Structural Beams - Welded Beams, Bracing Beams, Bracing Boxes• Ductings - Square, elbow, Transition, Circular.

• Analyse market strategy, perform Concept generation, Product Design & Proto Development with RPT exposure. (Innovation Project - RFP).• Experience in Bench Marking Methodologies / Product tear down analysis and Execution of projects using top-down design and Reverse Engineering methodology.• Analyze, Design & Development of components as per design requirements.• Process - Material selection, method of production and achieve the target of developing the product.• Design - Plastic components, casting parts, Sheet metal and Machining component design.• 3D CAD tools – Solid works, Pro-E, Unigraphics & AutoCAD. • Jig & fixture design, Protocol development for functional testing - partwise /Assembly wise.• Analysis - Application FMEA, Design FMEA and Process FMEA.• Trouble shooting at every stage of manufacturing & assembly.• Work with Standards ISO/IEC 60101-1 and applicable EMI / EMC.• Documentation – Inspection plan, functional test plan, manufacturing process sheets, BOM, User manual & drawings• Arrive the costing for the product, Part wise/Assembly wise.• Establish continuous feedback and design improvements within project execution period.Significant Projects: • Critical care Ventilator• Respiratory Humidifier (PH 100)• Humidifying Chamber (PH 100)

• Analyze market strategy, perform Concept generation and Reverse Engineering methodology.• Product Design & Proto Development. • Design & Development of alpha proto as per design requirements.• Perform Selection of material, production method and achieve the target of developing the product.• Design Jigs & fixtures.• Prepare Manufacturing drawings of individual sheet metal, plastic enclosure and machining components along with 3D model with exploded views. • Prepare and conduct test protocol functionally for individual parts & Sub-Assemblies.• Cost Estimation for each part/Assemblies.• Trouble shooting at every stage of assembly.• Perform Design FMEA.• Work in Standards IEC 60101-1 and applicable EMI / EMC.• Follow up the developing components for operational sequence.• Prepare Bill of materials.• User manual & drawing preparation.Significant Projects• Contrast Sensitivity Chart Projector. Measuring visual acuity...• Auto Refractometer (RF10) & Auto Ref- Keratometer:• Applanation Tonometer • Sterilizer

• Performed NDE Methods i.e., PT, MT, UT and RT and collaborate with mechanical testing team to perform destructive testing of Raw material at incoming stage and FOT samples in Mechanical Testing Lab.• Prepare PPC for the first batch production.• Monitoring stage-wise inspection in shop floor.• Responsible for achieving the targets, prepare Daily Reports and assisting in TQM Report.• Responsible for effective utilization of materials and labour. • Continuous Interaction with Production dept. for feedback of various Non-conformances in production line.• Identify and highlight if any Non-conformances, rejections, reworks & deviations in production line.• Involved in ISO 9001:2000 certification. Generate daily reports to assist TQM Reports.