Ketki Dhananjay Tembhurnikar
Nagpur
Summary
Dynamic Senior Engineer with TATA Elxsi, skilled in SolidWorks and product labeling. Successfully managed labeling deliverables and conducted gap analysis to align with ISO 13485 standards. Proven ability to collaborate effectively and drive project success through strong time management and strategic planning.
Overview
3
3
years of professional experience
Work History
Senior Engineer
TATA Elxsi
Pune
09.2022 - Current
- Prepare a CAD model for the packaging of medical devices in SolidWorks software.
- Prepare labels using Adobe Illustrator.
- Managed development and release of all Product Labelling deliverables.
- Conducted gap analysis comparing product standards with current QMS requirements.
- Identified discrepancies and developed roadmap for implementing labeling engineering changes.
- Created project plans to align with Regulatory and Business Unit deadlines.
- Applied requirement management from user needs through verification and validation.
- Collaborated with onsite and offshore coordinators on submissions and implementation activities.
- Supported project management activities including AOP and WSR.
- Documented project progress and provided regular updates to key stakeholders.
- Good understanding of QSR/QMS requirements as per ISO 13485:2016 and 21 CFR Part 820.
Education
Bachelor of Engineering - Mechanical Engineering
SBJITMR
Nagpur03-2021
HSC - Science Education
P.B.V.V.
Nagpur05-2017
SSC -
P.B.V.V.
Nagpur06-2015
Skills
- SolidWorks, Creo, and Catia
- AutoCAD and Adobe Illustrator
- Product labeling and gap analysis
- Time management skills
- Microsoft Word, Excel, and PowerPoint
Personal Information
- Date of Birth: 23/12/1999
- Gender: Female
- Nationality: Indian
Hobbies and Interests
- Mechanical Designing
- Kathak Dance
- Cooking
- Gardening
- Reading
Projects
- Design and analysis of a solar-operated MSW cleaning machine
Designed a solar-based roadside cleaning machine that ensures dust and dirt on the sides of the road are cleaned, the cleaning machine is an approach to deliver easy and time-efficient cleaning of roads by reducing human effort
A patent for a solar-based solid waste management machine (Patent No. 2021106072 was granted by the Government of Australia on November 3, 2021
- SUPRA
Supra is organized annually by SAEINDIA, with the support of Maruti Suzuki; we participated in this competition in 2019 Where we present our self-built vehicle and present the analysis report of it, on this basis we secured 85th rank all over India and 1st rank from the Vidarbha region
- Prototype for charging the battery from exhaust gas
This mini project explains how we can generate electricity using exhaust gas, and the turbine uses waste exhaust gas to produce electricity We use a silencer for both power generation and rural electrification, and the turbine produces electricity, which is stored using a battery Both the turbine and the battery are carefully placed in their respective places The stored electricity can be used for our specific purposes.
- Internship
Intensive training for BAJA virtual round presentation during this internship, I learned how to design a vehicle for the BAJA competition using SolidWorks software
Disclaimer
I, solemnly declare that all the above information is correct to the best of my knowledge and belief.
Languages
- Hindi
- English
- Marathi
Weaknesses
- Impatient
- Too detail-oriented
Timeline
Senior Engineer
TATA Elxsi
09.2022 - Current
Bachelor of Engineering - Mechanical Engineering
SBJITMR
HSC - Science Education
P.B.V.V.
SSC -
P.B.V.V.