Harishkumara K B
Technical Lead – Medical Devices | Design & Development | ISO 13485 Lead Auditor | Electromechanical & Disposable Devices | SolidWorks | Risk Management | EU MDR GD&T|Tolerance stackup
- Role
- Technical Lead at HCLTech
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Harishkumara K B
Transforming ideas into world-class medical devices\" A vision-driven leader in…
Experience
Technical Lead
Jun 2025 — Present · IN
Leading the design & development, Sustenance of a Class II software-controlled electromechanical drug delivery device) in compliance with ISO 13485, FDA 21 CFR 820, and IEC 60601/62304.• Developing SolidWorks 3D CAD models, 2D drawings, and GD & T applications, ensuring manufacturability and robust tolerance control. • Managing design data, revisions, and configuration control through EPDM Sigma Vault.• Preparing and maintaining Design History File (DHF), Device Master Record (DMR), and Technical Center Unit (TCU) documentation for regulatory compliance. • Executing change control activities including impact analysis, approvals, and documentation. Collaborating with cross-functional teams for integrated product development and design transfer.
Education
SVVRHS aranakatte
Bachelor of Engineering - BE, Mechanical Engineering/Mechanical Technology/Technician
Sri Channabasaveshwara Institute of Technology, GUBBI
Bachelor of Engineering - BE, Mechanical Engineering
2015 — 2019
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