Uday Kumar Gupta
Pune, Hyderabad
Summary
- A competent professional with nearly 9 years of rich experience in executing the design and development process, project execution and implementation, sustaining and engineering services, targeting assignments in the domain of medical device R&D lead, project execution, testing, documentation, and regulations. I love to contribute and learn from my passion and skills to the projects, and achieve successful delivery.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Senior Engineer
Cyient Ltd. Client - Boston Scientific
Pune
04.2023 - Current
- Product Support & Troubleshooting: Investigate and resolve design-related issues, including non-conformances, complaints, DCA and failure analysis.
- Design Improvements & Changes: Redesign or requalify mechanical components due to obsolescence, supplier change, or compliance updates.
- Regulatory & Compliance Support: Update and maintain Design History Files (DHF) and Device Master Records (DMR) for sustained compliance.
- Verification & Validation (V&V): Collaborate with quality and regulatory teams to determine the impact of changes and revalidation needs.
- Manufacturing & Supplier Support
- Cross-functional Collaboration
- Sustaining Documentation & Tools: Utilize PLM systems (Windchill, Agile) and CAD tools (SolidWorks, Creo) for managing design changes.
Sr. Engineer
Cyient Ltd. Client - Thermo Fisher Scientific
Hyderabad
10.2021 - 03.2023
- Led project for new product development by analyzing and deconstructing competitor products.
- Designed and developed mechanical components for medical devices using SolidWorks.
- Ensured compliance with Design Control regulations under 21 CFR Part 820 and ISO 13485.
- Developed test plans, protocols, and reports for verification and validation of mechanical designs.
- Created and assessed rapid prototypes through 3D printing, CNC, or injection molding.
- Provided Sustainable technical support for field complaints and CAPA investigations to enhance products.
- Compliance and Regulatory Support: The IEC 61010 centrifuge standard regulation follows up while testing the device.
- Applied Six Sigma methodology to optimize processes.
Sr. Engineer
Mukunda Foods Pvt. Ltd
Bangalore
08.2020 - 09.2021
- Technical Ownership: Own the technical roadmap and ensure that design aligns with product requirements, user needs, and functional goals.
- Team and People Management: Mentor, coach, and manage a team of R&D engineers (mechanical, electrical, or software, depending on the domain).
- Cross-functional Collaboration: Work closely with Product Management, Manufacturing, Quality, and Supply Chain to ensure product feasibility, manufacturability, and cost-effectiveness.
- Innovation & Product Improvement: Identify opportunities for product innovation, value engineering, and cost reduction.
- Tools & Process Optimization: Promote the use of industry best practices, Agile or Stage-Gate methodologies.
Engineer
L & T Technology Services
Bangalore
05.2017 - 07.2020
- Executed NPD design optimizations, completing prototypes while ensuring adherence to specifications.
- Created detailed designs for plastic, sheet metal, and machined parts along with DFM and DFA documentation.
- Maintained thorough Design History Files (DHF) and Device Master Records (DMR) for regulatory compliance.
- Employed Six Sigma methodologies to drive continuous improvement initiatives.
- Selected appropriate electro-mechanical components such as motors and sensors based on functionality.
- Developed rigorous test protocols to verify design specifications and validate user requirements.
- Conducted comprehensive risk analyses per ISO 14971 utilizing DFMEA and FTA methodologies.
- Collaborated cross-functionally with quality, regulatory, manufacturing, marketing, and clinical teams.
Trainee Engineer
Tata Power Solar
Bangalore
04.2016 - 04.2017
- Product Research & Development
- Performance Optimization
- Testing & Validation
- Cross-functional Collaboration
- Sustainability & Compliance
Education
B-TECH - Engineering Technology
BITS Pilani
Diploma - Mechatronics
NTTF Bangalore
Skills
- New product development
- Idea generation
- Design for Excellence
- Design of Sheet Metal
- Machining
- Plastics parts
- ASME
- DFM
- DFA
- GD&T
- Tolerance Analysis
- FEA
- System integration
- Prototype Building
- Design Verification
- Design Validation
- Sustaining projects
- CAPA
- DFMEA
- Electrical components selection
- Collaboration with software teams
- Collaboration with electrical teams
- Collaboration with global teams
- Six Sigma methodology
- ISO 13485 (Quality Management System)
- ISO 14971 (Risk Management)
- CFR 82030 (Design control)
- (EU) MDR 2017/745
- IEC 61010-2-020
- ISO 15223
- EN 1041: 2008 (IFU)
- MDR remediation
- Windchill PLM
- PTC CREO 40
- SolidWorks 2016
- Advance Power Excel
- PPT with AI
- Microsoft Word
Certification
EU-MDR 2017/745
Accomplishments
- Star Employee of the Month
- Best Team of the Month
Certification
I hereby declare that the above information is true to the best of my knowledge and belief. I take full responsibility for the correctness of the same.
Timeline
Senior Engineer
Cyient Ltd. Client - Boston Scientific
04.2023 - Current
Sr. Engineer
Cyient Ltd. Client - Thermo Fisher Scientific
10.2021 - 03.2023
Sr. Engineer
Mukunda Foods Pvt. Ltd
08.2020 - 09.2021
Engineer
L & T Technology Services
05.2017 - 07.2020
Trainee Engineer
Tata Power Solar
04.2016 - 04.2017
B-TECH - Engineering Technology
BITS Pilani
Diploma - Mechatronics
NTTF Bangalore
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