• Lead Medical device R&D Projects in Continence Care division – Class 2 Devices (Intermittent Catheters)• Develop new products by alternate material change – Environmentally friendly approach. • Maintain Device’s Design Controls per ISO 13485 and FDA 21 CFR 820.• Analyze and Initiate R&D Core Business opportunities to achieve cost savings through change control-Design control.• Manage contract manufacturing projects – Male External Catheter Shelf-life evaluation.

R&D Project Delivery Responsibilities May 2014 to April 2023Delivery Excellence:• Managed to deliver medical device R&D projects with a team of 30+ professionals.• Defined the strategy, and business proposals for Medical Device Sustenance Engineering portfolios, Test Method Validation and DHF Remediation programs.• Managed Medical devices (Class 1 & 2) Design Controls to ensure Regulatory compliance.• Worked closely with Cross-functional team - Manufacturing, Design quality assurance, Global Quality, Clinical and Regulatory for smooth execution of projects.• Developed strategic initiatives to improve the effectiveness of project deliverable, customer value creations through six sigma initiatives.• Supported senior management to develop account level key strategy plan, vision statement.• Visited and collected Project inputs from Baxter Renal care facilities – Germany-Hechingen, France-Meyzieu, Italy-Medolla.Team Management:• Responsible for setting team goals, coordinating tasks, providing guidance and support, and ensuring the team's success.• Demonstrated leadership skills by effectively engaging the team to achieve their performance efficiency.• Trained and supervised Senior Engineers to deliver independently on assigned task.• Hiring, training, creating development plans, motivating, and retaining skilled employees.

Teleflex Incorporated: Feb 2021 to Oct 2021New product development support – Laryngoscopes, Phase: Feasibility• Developed Endoscope camera module- Mechanical enclosure design IP 67• Design Feasibility analysis, Risk assessment, technical review, Proto build and supplier interaction EU MDR Assessment, Annex I - General Safety and Performance Requirements• Usability Engineering assessment per EN62366-1 Annexure C - UOUP Report for Urology productsAbbott Laboratories: Aug 2020 to Feb 2021• Test Method Development – Characterization, Protocol and Report preparation for Design Test methods for Structural Heart (SH) Delivery system – Catheters and Occluder- Amplatzer• Process Validation – IQ/OQ/PQ – Protocol and Report, Manufacturing procedure• Change Management - Change Order – Create and Execute Change Activity in Windchil• Rebranding project – AGA, St. Jude Medical to Abbott for QMS documentationBaxter International Inc: July 2018 to Aug 2020 Acquisition support for Product Data Integration per Design controls/Corporate QMS• Migration of Product data from legacy system into Teamcentre Unified PLM system as Structured, standardized and created relation to product data. Master data management in Teamcenter PLM• Device Master Record (DMR) creation and Design History File (DHF) Structuring,• Renal - Hemodialysis – Filter (Dialyzers) Product data transformation into Teamcenter PLM

Project Lead: Baxter International Inc.Infusion System – Spectrum Infusion Pump Development project Successfully delivered the Test Fixture Design and Drawings, Interacted with Supplier for prototype fixture development, Supported in Verification & Validation of Test Fixtures.Remediation of UDI & GUDID, Design History File (DHF) Structuring per FDA design control, Gap assessment, DMR/DHF/BOM Structure.Reviewed Product design control documents – DHF/DMR, Production process control documents – IQ/OQ/PQ.Change Control Management (CCM) using Trackwise tool, Document control through Teamcentre Unified (TcU)Post Market Surveillance – Complaint Handling support,Compliance Engineering – Standard Gap Assessment support, MoC Assessment (REACH, RoHS).

Project Lead: Baxter International Inc.Test Method Validation Projects (TMV) per 21 CFR 820, Gap Assessment, Protocol create & update and Report preparation for medical devices – Class 2 and Class 3 Devices.Created Test Method Validation Evidence Traceability matrix and its Requirements linked in DOORS tool.

MV & LV Drives / Switchgear - Design & Development • Provided Mechanical design support for varies types of Drives Cubicles / Enclosures and prepared fabrication, Assembly drawings & Bill of Materials• Designed Mechanical frame with Load calculation for Transportation of MV7000 Drives and Prepared procedure for Handling & Transportation of Drives• Performed load calculation for drives skids (Platform) and ensured it meets the functional requirements.• Sketched 2D drawings and designs using CAD programs to provide detailed design and specification.• Created Bill of Materials, Material Master and Engineering Change Management activities in SAP• Consulted with other engineering functions for clarification and resolving potential problems.• Contributed positively to business achievement plan and overall success of design team through consistent performance.

Elevator Cabin Design: Duration: 1.2 Years• Customized Design and Development of Elevators system for perfect installing in various part of the world.• Designing of CAB parts includes Panels, Doors, Ceiling and Platform by using sheet metal.• Study of layout drawings for design according to Clint’s requirements.• Planning and Scheduling for the project assigned.• Preparation of detailed manufacturing drawings & part list using an AutoCAD tool.

Interior Design: Duration: 10 Months• Customized Interior Design for Commercial Buildings, the design includes Glass Partitions & fittings and Shower cubicle design for varies Apartments. • Preparation of BOM, Cost Estimation and Quotation for the Project Proposal. • Preparation of detailed production drawings & cut out drawings for Toughened Glass.• Detailed study of Building layout drawings and documents.• Site visits and prepare customer layout (Measurement) drawings.• Providing the Finest Solution to the Customer

Provided Training on Mechanical tool packages (Auto cad, Pro-e 2001 & Wild fire 2 and MSC Nastran) > Created 2D Layout drawings for varies Machines and Commercial building plan drawings