Experience

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  Hcltech

  Aug 2018 - Nov 2020

  Mechanical design engineer

  Mechanical Design Engineer, worked in design quality and regulatory affairs domain of medical devices for EU market.Project 1: HillRom EU-MDR regulatory compliance project of Active medical devices (Class IIa and IIb).Experience in below areas:1. EU-MDR Remediation Projects.2. Design Control Projects-DHF Remediation, CTQ, PSD and Design Input/Requirements creation and Verification of DIs.3. Product design and development (right from concept to final prototype).4. providing Internal Training on topics like regulatory standards, EU-MDR GSPR, Technical Documentation as per MDR Annex II.5. Review of MDR Gap Assessment files like GSPR, Tech file, V&V protocol and reports, Risk management files, product Specifications, Labelling and IFU specification documents.6. Client interaction and discussing on delivered files with clients.Medical Devices worked on: Active Medical Devices [Stress ECG, Ambulatory ECG ( Holters), Monitoring ECG, Resting ECG], Surgical Beds.Design Tools: CATIA, Teamcenter, SAP and NX CAD, Electronic GSPR and DOC tool.Project 2: Electrolux EU Design and development Project- Italy.worked as Mechanical Design Engineer and lead engineer.Scope of work: 1. Design of refrigerators (interior and packaging products) using concept to final CAD design/model via Reverse Engineering.2. Design change to reduce cost and to make product cost effective using DFM and DFA.3. Was handling individual design of connectors and harness project for client Electrolux.4. Providing ideas for reducing cost by design changes in refrigerators systems.Tools used: CATIA V5 , Teamcenter, Zuken E3( Harness Tool). Show less

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  Tata elxsi

  Nov 2020 - Nov 2021

  Senior engineer

  Worked in design development and Regulatory Affairs domain of medical devices as product development engineer.My contribution in Tata Elxsi is as below:Project 1: EU- MDR Regulatory compliance project.Medical Device scope: Hip Implants ( Acetabular Components).Scope of work: Review of MDR Gap assessment files and below listed remediation files.1. Design of Implants, Product Specifications doc, Risk management files.2. GSPR and Technical Documentation.3. V&V protocol and reports.Client interaction and discussing about GSPR and remediated DHF files.Project 2: Design Control project (DHF Remediation ) *Got Bravo Award for good contribution to project Zimmer Biomet*Medical devices scopes: Total Hip Implants and External Fixation system implants.Scope of work: Remediation of complete DHF files to close the CAPA raised by BSI audits and to comply with 21CFR820.30 and ISO 13485.worked on below files:1. User need requirements and Design Input creation.2. Design Verification and Validation.3. Remediation of risk management files (PHA, FMEA, RCTM and ORBA).4. PSD and CTQ using CAD drawings.5. Updating CAD drawings and solid models for non compliance devices using NX CAD.Actively involved in client interaction and discussion with clients to close DHF remediation gaps. Show less

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  Capgemini

  Nov 2021 - Apr 2022

  Associate consultant

  Worked in design and development of medical devices and reverse engineering.

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  Medtronic

  May 2022 - Sept 2023

  Quality engineer ii

  Design Engineer working in design & development, Quality and Regulatory Affairs of medical devices. worked on devices like Diabetes insulin pump and Neurovasular products.

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  Danaher corporation

  Sept 2023 - now

  Senior mechanical engineer