Madhan Kumar R
Sr. Product Owner@ Medtronic | CSPO, CSM
- Role
- Senior Product Owner at Medtronic
- Location
- Minneapolis, MN, US
- LinkedIn followers
- 500 followers
About Madhan Kumar R
As a Senior Business Analyst at Medtronic, I leverage my 15+ years of experience in…
Experience
Senior Product Owner
Aug 2020 — Present · Mounds View, MN, US
Created Software Requirements Specifications (SRS) and Functional Design Documents for DTRAK and ServiceNow CMF.• Coordinated with teams (mSTAR, Carelink, Mendix PEMS, ServiceNow, GCH) to ensure 100% accurate device and patient data flow across systems and verify the functionality of ServiceNow applications like CMF and Get Connected• Ensuring compliance with FDA Quality System Regulations, EU MDR, ISO 13485, ISO 14971, IEC 60601, and other relevant industry standards during product development and changes.• Good experience in implementing FDA\'s 21 CFR Part 820 requirements for medical device manufacturers, including design controls, document controls, CAPA, and record-keeping.
Education
University of Madras
Master of Business Administration (MBA)
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