
Santhoshkumar Vijayakumar
Mechanical engineer with around 12+ years of work experience in Mechanical and Medical Device Engineering industries. New Product... | Grayslake, Illinois, United States
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Santhoshkumar Vijayakumar’s Emails sa****@fl****.com
Santhoshkumar Vijayakumar’s Phone Numbers 91787186****
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Santhoshkumar Vijayakumar’s Location Grayslake, Illinois, United States
Santhoshkumar Vijayakumar’s Expertise Mechanical engineer with around 12+ years of work experience in Mechanical and Medical Device Engineering industries. New Product Development in Medical devices and DHF remediation performed for Regulatory compliance. Analyze the new Medical Device Regulation (MDR – 2017/745) and assess the medical device as per device-specific Biocompatibility & Chemical characterization requirements and its contact classification as per the below process. Special report preparation with rationale, Discussion with external manufacturers to get test reports and safety information of raw materials for the remediation. Preparing the remediation plan, gap summary, and prioritizing the gaps based on the product impact assessment in each Global Business Unit. Product requirements and User needs are Creating Technical Requirements in NPD. Gained significant exposure in Product Designing as per ISO 13485-MQMS, and ISO 14971. Demonstrated excellence in enhancing product design operations, performing process failure mode effects & analysis, and escalating productivity &operational efficiencies. Performing Risk Management activity as per ISO. Trace Matrix, Toxicology Matrix, and Verification & Validation were also performed on the Product.
Santhoshkumar Vijayakumar’s Current Industry Hcltech
Santhoshkumar
Vijayakumar’s Prior Industry
Flsmidth
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Hcl Technologies
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Hcltech
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Hcl America
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Work Experience

Hcltech
Senior Technical Lead
Sun Oct 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Hcl America
Technical Lead
Sun Oct 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Hcl Technologies
Technical Lead
Wed Aug 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Oct 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Hcltech
Technical Lead
Wed Aug 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Oct 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Flsmidth
Lead Engineer
Thu Dec 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Aug 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)