Sebastian Manoj C

Client : Onsite - Medtronic,Hyderabad

Project : Transitional Standard Assessment,Quality System Change Implementation

Nature of Work : Remediating Risk Documents for Neuromodulation Portfolio

Tools : MRCS (PLM),PTC,Enovia

• For risk documents pertaining to its line of Neuromodulation products, Medtronic established its own archive.
• After 2019 publication of ISO14971, Medtronic intends to update its risk documents to comply with these new specifications.
• Internal procedural requirements for Medtronic, known as QSY (Quality System Change Implementation), have been updated and seek to be updated depending on most recent information.
• Involved in creation of Risk Management Plan, DFMEA, UFMEA,Hazard Analysis, Risk Review Record, and Risk Management Report.
• Completing traceability of Historical documents and remediating Risk Management Plan based on product therapy, description, and appropriate requirements.
• Updating Hazard Analysis to reflect the most recent standards and checking references.
• Updating questions based on the product's quantitative and qualitative characteristics, which aid in identifying hazards and hazard sources for Hazard Analysis.
• P1 and P2 data refreshments were created using complaints or available sources.
• Checking the Residual Risk Classification values using P1 and P2 calculations according to organizational needs.
• Provide justification for any modifications to Risk Review Record for products where the final Residual Risk Classification changes (increases or reduces).
• Adding Overall Remaining Risks to Risk Management Report, together with Reason for Risk Acceptance Criteria and Monitoring Risks.
• Worked in Risk management Pre-market and Lifecycle change requests.
• Updating PSUR for items in Class III.
• Implementing test method validation and creating TMV protocol, report, deviation reports, and doing statistical analysis with Minitab are all examples of test method validation.

Project : MDR-Spine (Johnson & Johnson)
Nature of work : EU MDR - Risk Management Document Creation and
Remediation
Tools : SAP, Adaptiv and Windchill

• Johnson and Johnson Medical Devices which are in market per MDD Regulations of European Standards need to satisfy MDR regulations with Remediation of :
• Risk Management Documents like Risk Management Plan, Risk Analysis
• Checklist, Design FMEA and Risk Management Report
• Creating new MDR compliance Documents which doesn't have any MDD legacy objects.
• Confirming Techfile Product scope based on Family brand, planning for remediating activity by listing relevant legacy documents.
• Prepare Risk Analysis Checklist based on product type by understanding its functions and intended uses in surgery perspective.
• Compiling all associated foreseeable risks, arrive Severity and Occurrence based on company Standards.
• Analyze Post Market Surveillance and clinical complaints data to find out Occurrences.
• Mapping recommendations to reduce risk level for Higher levels of Risk Derive Risk Management Report for residual risks
• Interacting with client regarding process requirements.
• Coordinating with various team for getting required inputs and additional data.
• Creating and follow up Electronic Document Management and Revision control through PLM approval processes.
• Collaborated with client and interdepartmental peers to transform client requirements into turnkey solutions.

Projects: Torque Plate Casting for LCV,Housing for Steering Assembly,Pump
Housing for Brakes
Nature of Work: Product Design and Development, Product tool Design
(Pattern), APQP Documentation
Tools: NX-Ideas 6.5,Solidworks,AutoCAD

• Performed Feasibility study for New Product Development on Designing, Production and Cost Aspects.
• Framed APQP Timing Plan with Cross Functional Team,and aligning with that to Deliver product within Timeframe.
• Design and Develop pattern tool for products.
• Design Gating / Methoding system for Sand Casting Process. Make Pattern Manufacturing and Inspection Drawings with GD&T controls.
• Validate manufactured tool and Prepare Work Instructions for Production.
• Contribute in scoping, analyzing gap in current design by challenging to improve in areas manufacturing, inspection, GD&T, V&V, design documents.