Sathish Kumar P

Experience

1. Senior Engineer

   L&T Technology Services

   Sep 2022 — Present · Bengaluru, IN

   DHF Remediation for re-called products in human respiratory system such as Ventilator, Sleep therapy device Support and executing the projects with respect to V-Model.(Thorough understanding of medical device design control procedures for design & development) Lead & support verification and validation activities for system & subsystem levels MDD & MDR Gap analysis in the current product QMS & making GAP closure plans, submitting documents for MDR & MDD extensions with the local body Interactions with cross functional teams (Design, Operations, quality, supplier, clinicians, Labeling & packaging unit to understand the gaps in current design control documents w.r.t latest std\'s compliance by FDA & EU MDR Process validations & verifications for medical equipment’s conducting IQ, OQ & PQ Lead & support onsite production team to write Master validation plan, test protocol, Risk assessment (FMEA), Statement of procedure (SOP), URS & test execution strategies planning Lead & support measurement system analysis: Gauge R&R Study to analyse the measurement variations, accuracy in instruments/tools used in production floor.(Part & elements manufacturing lines of ventilator & sleep therapy devices) in ANOVA statistical technique Test method validation: Protocol writing for new verification/validation methods, decision making on MSA studies & final report preparation.(Worked alongside with onsite SME’s & lead to gather data & sampling information’s) General safety & performance requirement (GSPR) document preparation with applicable std\'s & verification trace reports for products MDR extension. Preparing Part, element level DFMEA’s & Risk assessment for process (PFMEA’s). Medical Std\'s decomposition activity & analysing the Gaps in the current design control documents of Devices.(Std\'s includes ISO 13485, ISO 14971, IEC 60601 & Collateral std\'s, ISO 15223, ISO 20417, ISO 17664, ISO 62304 & EMI/EMC Std\'s)