Madhukanth K Email & Phone Number

New York, United States

United States

Mansfield, Massachusetts, United States

Coordinate with production team and Engineers to remediated the Gaps and apply the changes to the production areaConduct Weekly meeting with cross-functional teams to review the progress on the PFMEAs and DFMEAs for compliance with EUMDR standardConduct weekly team meetings and assess the progress of the resources on their assigned tasksPlan and delegate work within EUMDR team resources for Patties and Perforator Products for Remediation of the GapsProvide updates on Weekly Global Team meeting representing Mansfield Plant Quality, Manufacturing, Validation and OperationsPerformed Gap Assessments on Patties, micro-patties and strips manufacturing processes, equipment and packagingPerformed Gap Assessments on Perforators, Craniotomy kit, hand drill and Cranio blades manufacturing processes, equipment and packagingWell versed with Agile Product Life Management System, Oracle R12, Transcat C3 and EtQ.Created Validation Assessment Forms for new and existing custom fixtures.Created Master Validation Indices for multiple products. Handled and closed in process deviations and discrepancies.Updated Master Validation Protocol, created process flows and cleanroom Maps.Authored, Executed and reported TMV for perforator pin lubrication testing by applying Hydrophobic resin.Updated drawing using AutoCad for External Manufacturing products by applying GD&T principlesPerformed visual inspection, gathered seal strength data using Venuturo Peel Tester and determined statistical IMR and process capability using Minitab Analysis

Mansfield, Massachusetts, United States

Elkton, Maryland, United States

Developed and implemented RTMs, Manufacturing Procedures and Engineering Drawings for IK product family and closed CAPA of missing procedures, Traceability Matrices and drawings for IK product familyPerformed testing on Keyence Machine to investigate the nature of foreign material and determined the root cause asmachine ware. Implemented Preventive Maintenance Schedules and Data collection systems to perform, record and report preventive maintenanceInvestigated and Resolved Non-Conformance of GSS Product not performing as specification. Identified root cause,dispossessed the product to scrap. Material in the pick list was faulty and reported to the vendor and requested newstock with the help of Supplier Quality and updated the incoming inspection methods to eliminate reoccurrence.Supported Manufacturing Equipment Material Change for Sheath Manufacturing process, Execution support forManufacturing Engineer and reviewed and approved Final Report.Investigated and Resolved Non-Conformance of Foreign Matter Presence in GS and GSS products. Identified root cause,implemented a system to schedule and enter equipment maintenance and cleaning after every lot to avoid Materialware and Equipment Grease Spillage.Investigated and Resolved Non-Conformance of wrong Manufacturing Parameter being used for IK productManufacturing. Identified the root cause, retrained Operators and Implemented Documentation System for enteringValidated Parameters prior to beginning of the operation to eliminate the error from reoccurring.Updated the PFMEAs and RTMs of IK, GS and GSS product familiesResolved manufacturing and quality issues (including troubleshooting of production equipment, investigating root causes of device and component failures, writing NCMRs)

Naples, Florida, United States

Used GD&T to interpret designs, blueprints, and engineering drawings. Implemented and managed Design History File (DHF), Functional design requirements, design input and output (I/O),design Verification and Validation (V&V), and design risk management analysis.Developed and executed Test Method Validation (TMV) protocols. Performed Gage R&R studies. Prepared TMV reports.Maintained Design History File (DHF) to ensure its full procedural and regulatory compliance and readiness for audits.Performed Design/Process FMEA’s and CTQ activities to establish controls for process variablesStreamlined new designs for manufacturing. Established Process Specifications.Conducted design of experiments (DOE) to identify critical variables in a process and established design limitations.Reviewed specifications and equipment design and builds at outside suppliers and determined machine acceptance and potential changes at equipment Factory Acceptance TestsContributor in process improvement Kaizens to optimize process flow using lean & six sigma tools resulting in improved production yieldsWrote equipment qualification protocols and reports (IQ and OQ).Led investigations of non-conforming situations to determine root cause, containment, and design impact. Compiled technical reports in support of NCMR investigations, CAPAs and containment activities used to support quality decisions.Led all product design related corrective and preventive actions (CAPAs). Ensured that CAPAs are completed in timely manner with root causes investigations and supported corrective actions that are commensurate to the risk of issue being corrected