Consultant (Global Labeling Engineer) at Atos Pvt Ltd (2022-02 – Present)
Leading global labeling implementation projects for multiple product portfolios, ensuring compliance with US FDA, EU MDR, and UDI regulatory requirements.
- Successfully led global labeling implementation projects for multiple product portfolios, ensuring compliance with US FDA, EU MDR, and UDI regulatory requirements within project timelines
- Delivered end-to-end labeling updates for NPD and design change projects, coordinating cross-functional stakeholders and enabling successful regulatory submissions and product launches
- Streamlined label approval workflows and document review cycles, reducing approval turnaround time and improving project delivery efficiency
- Led UDI implementation and labeling data integration initiatives, ensuring accurate product data management and regulatory database readiness
- Executed large-scale labeling remediation projects to align legacy products with updated regulatory standards and internal quality system requirements
- Successfully coordinated multi-language labeling translations with global vendors, ensuring regulatory compliant labeling across multiple international markets
- Led CAPA and complaint investigations related to labeling issues, implementing corrective actions to improve product labeling accuracy and compliance
- Improved labeling documentation consistency by implementing standardized templates, procedures, and process improvements
- Collaborated with Regulatory, R&D, Marketing, Packaging Development, and Manufacturing teams to deliver compliant labeling solutions during complex design change projects
- Contributed to process automation and labeling system optimization initiatives, improving labeling data management and reducing manual errors
Lead Engineer at HCL Technologies Ltd (2019-06 – 2022-01)
Lead Engineer for EU MDR Gap Assessment and Remediation project for labeling and technical file, working with BD (USA) as client.
- Act as a project originator to perform Labeling and Technical file Gap Assessment with respect to General Safety and Performance Requirements (GSPR) annexures present in EuMDR regulation (2017/745)
- Perform as a primary point of contact for the labeling project and also perform to lead labelling meeting with cross functional team, Plant team and Change coordinator to get the conformance in order to submit the file in to the notified body
- Expertise in remediating the Labeling from MDD to EU MDR regulations for medical devices by creating the redline for affected packaging labels
- Performing the Standard Gap Assessment with respect to ISO 15223 (Symbols to be used with information to be supplied by the manufacturer) and ISO 20417 (Medical Device-information to be supplied by the manufacturer)
- Review and approve Risk management and product labeling to ensure compliance with regulatory requirements
- Successfully incorporated regulatory requirements in to engineering changes through effective collaboration with Cross functional team and change coordinator
- Perform EUMDR gap assessments to determine the device classification and rules in order to make it compliance in technical file
- Act as SAP (Everest and Tahiti) PLM to uploading the Design History Files (DHF) in SAP after getting cross functional team approval
- Organization activity – Act as a Defect preventive analyst (DPA) for to control the errors in the project
- Prepare IRR (Internal Review Record) in each delivered products for to identify the defects and documented the same in DPA workbook and initiate CAPA wherever necessary
- Folder structure maintenance and document version control
- Coordinating with onsite engineer for project requirements and workflow very effectively
Senior Product Design Engineer at Cyient Ltd (2018-06 – 2019-05)
Senior Product Design Engineer for New Product Development of JM-1000 Geared turbofan engine for Pratt & Whitney (USA).
- Team leads for Fan Case & Rotors: Handled a team of 5 members, for the development of a new fan case engine component (PIP-A) to increase fuel efficiency and for the improvement in noise level as this hybrid engine
- Worked on developing total modeling of fan cases at both part level and assembly level
- Did a clashing study with the existing externals with new stress-measuring devices (Piping and electrical Routing to add the NSMS Probes)
- Stack-up analysis with all the externals added to the fan case
- Clashing Study with the externals and feasibility check to assemble the engine with externals
- Addressing the Non-conformance areas for the machined components by conducting structural analysis and simulation on the existing production modeling
- Rotors Gear Spline Modification in High-Pressure Compressor
- Handling Deliverables related to sub-components and Non-conformances
Tooling Design Engineer at Tata Hal Technologies Ltd (2017-08 – 2018-05)
Product Design Engineer & Tooling Engineer for Tata Sikorsky Aerospace Ltd working on GE products.
- Design of High-pressure compressor for GE leap engine, compressor casings, split casing
- Roller conveyors, Open Gate conveyors designed for shop floors
- Model validation- Analyzing the 3D model against the Tolerance's
- Creating Machine Operating Sheet for aero-engine parts
- Design of assembly fixtures, Drilling Jig for Sheet Metal Components
- Machining Fixtures – Milling & Turning fixtures for Rolls Royce & General Electric Components
- Fixture prove out on shop floor
- Both concept design and detailed drafting and releasing it to sub-vendor
Tooling Design Engineer at Nitesh Engineering Works (2013-11 – 2017-07)
Tooling Design Engineer for product design, manufacturing and design of jigs and fixtures.
- Developed Design and Manufacturing of Open Gate conveyor, HMC, VMC, U-Cam fixtures, Washing Machines
- Design and manufacturing of jigs and fixtures
- Conducted review of vendor print documents/drawings
- Attending customer requirements and taking orders from customers and developing drawings
- Attending Customer queries and problem-solving if any
