
Karthik
Working as Risk management role focussing on end to end risk management for Renal care product with total... | Maharashtra, Maharashtra, India
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Karthik ’s Emails ka****@ph****.com
Karthik ’s Phone Numbers 1800257****
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Karthik ’s Location Maharashtra, Maharashtra, India
Karthik ’s Expertise Working as Risk management role focussing on end to end risk management for Renal care product with total 4.11 years experience in Medical device regulated industry focused on the System design and ISO14971 Medical device risk management( Certified Risk Manager by TUV SUD) Worked as System Designer in Philips Diagnostic X-ray R&D unit and handling LCM activities of multiple products. Played role of System engineer with end to end understanding of medical device development process with understanding of Requirement engineering, Model based system design, AGILE practitioner certified. Handled NPI/LCM activities for Fluroscopy based systems mainly working on the customer escalation technical analysis, Feature development based on market needs, end to end traceability of requirements. Also was part of FDA audit preparation team with good understanding of FR/BR setup, CAPA process, QSIT matrix and its preparations. Handled LCM activities as a part of system and starting from initial impact assessment to formal release as per Design control process in accordance with ISO13485. Playing risk manager role for multiple products including Diagnostic X-ray, Mammography, with experience in Risk management plan, Risk management matrix, Benefit risk determination and risk management report as per ISO 14971. Also interned in IGT at Philips in mechatronics team and worked on mmWave based collision detection, capacitor based anti collision detection and validation of hybrid energy storage unit. Having an experience of 2 years in Bosch automotive electronics as senior engineer in manufacturing IT with good communication skills, A3PSS based problem solving, LEAN basics, Cpk study, quality tools. Trained on emotional intelligence and Basics of project management.
Karthik ’s Current Industry Baxter International
Karthik
’s Prior Industry
Bosch Automotive Electronics
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Philips
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Baxter International
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Work Experience

Baxter International
Sr.Engineer Risk
Wed May 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Philips
System Designer
Sat Oct 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed May 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
Philips
System Engineer
Sat Jun 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jan 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Philips
M.Tech intern
Tue May 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed May 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Bosch Automotive Electronics
Senior engineer in Manufacturing IT
Sat Aug 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jul 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)