Sandeep Vats
M Tech. CAD/CAM, Design Quality Engineer, ISO 13485, ISO 14971, EU MDR 2017/745, GD&T, Stack up Analysis
- Role
- Consultant (Design R & d - Boston Scientific) at Capgemini Engineering
- Location
- Gurugram, HR, IN
- LinkedIn followers
- 500 followers
About Sandeep Vats
Results -driven Design Quality Engineer with over 7+ years of experience in the medical…
Experience
Consultant (Design R & d - Boston Scientific)
Sep 2023 — Present · Pune, IN
Experience of remediation and creation of DHF documents for Balloon catheters.Working experience on creation/updating design control plan, design verification and validation plan/reports, design change assessment, IFU, Usability validation reports as per ISO for general requirements and safety, efficacy, and performance of PTCA balloon catheters as per ISO experience on creation/updating risk management documents, Hazard analysis, complaint analyses, occurrence assessment, DFMEA, Packaging Process FMEA as per ISO 14971, ISO 24971 and ISO of DHF remediation and creation of DHF documents for Multi Parameter patient monitor as per IEC 60601-1.Experience of DHF remediation devices like Infusion Pump as per IEC 60086 and Porcine Aortic heart Valve as per ISO 22442-1.Working experience of Product Lifecyle management software Windchill (creating and updating Parts, DHF Documents, DMR Documents, Process Plans, BOM, Process library documents, peer review documents, product and project documents).
Education
Thapar Institute of Engineering & Technology
Master of Technology - MTech
2016 — 2018
CGC College of Engineering, Landran
Bachelor's degree
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