Jithin Kumar Email & Phone Number

Bengaluru, Karnataka, India

• Developed and maintained dashboards that provide stakeholders with real-time insights into project status, progress, and performance in accordance with WIP plan.• Monitored the team performance through developed WIP dashboards, that track KPIs such as project schedule adherence, resource utilization to ensure on time delivery.• Performed analysis on the processes related to productivity, quality, costs, and time management.• Coordinated process improvement strategies with internal stakeholders.• Presented progress reports and integrating feedback.

Hyderabad, Telangana, India

• Performed an initial assessment of the complaint to determine its severity, and potential impact on patient safety.• Conducted a thorough investigation into the root cause of the complaint, which may involve reviewing production records (DHR), and analyzing other relevant data.• Maintained records of the complaint investigation process, including findings, actions taken, and any corrective or preventive measures implemented.• Categorized complaints into different types based on their nature, such as harm to patients, design issues, manufacturing defects, labeling concerns, or usability problems.• Analyzed complaint data over time to identify trends or patterns that may indicate broader issues with a particular product or process.• Reassessed the severity & occurrence of each identified risk considering the complaint data. • Strategically planned and delegated tasks to the team (150 people) for achieving the business goal.• Coordinated with global counterpart to understand business needs.

Pune, Maharashtra, India

• Maintained project schedule by monitoring project progress; coordinating activities; resolving problems.• Lead an offshore team of 15 members for the creation of technical documents and complaints handling.• Performed a comprehensive gap analysis of existing technical documentation and device labels against the new MDR requirements and identify areas where the current labels fall short of compliance.• Performed a comprehensive gap analysis on the existing Design History File (DHF) and Technical Documentation to evaluate its implications for design controls.• Created/updated the relevant documents as per new requirements list.o Product Risk Analysis.o Product Description, GSPR Checklist, LoAS, CMR Report.o Labels and Instruction for Use (IFU)o Test Plan and Test Report (Product V&V Rationale).• Identified potential risks and hazards associated with the design, development, and usage of the product.• Assessed the severity & probability of occurrence.• Ensured that mitigation plans were effectively aligned with their respective hazards, enhancing the overall risk management strategy.

Madurai Area, India

Device & Package Labelling• Performed gap analysis for legacy product families against all safety and performance elements.• Verified the labels per MDR (Annex I) & FDA (21CFR 801).• Ensured the symbols used on medical device labels comply with ISO 15223-1• Involved in Global and MDR Labelling Gap Assessment, responsible for Labelling mark-up, Label specification updates, coordinating in all the labelling content approval.• Created Labelling Requirement Specifications (LRS), and Master Content Documents (MCD) for labelling remediation as per MDR- European Medical device regulations. • Analysed gaps in the existing labels including- Shipping carton labels, Unit labels, Inner carton labels, Instructions for Use/ Patient/User manuals, etc. as per MDR (Medical Device Regulations). Verification & Validation• Identified tests or inspections that were performed on the medical device to meet the specified requirements.• Evaluated the test procedures to ensure considered method was validated.• Created Special reports (equivalency rationale), SOPs (Standard Operating Procedure), Protocols (sampling plan, acceptance criteria.), Final Reports (executed result as per protocol) for attribute and variable tests.• Designed and developed testing fixtures as per test requirements.• Validated test methods for R&D, In-coming, In-process and final inspections per 21 CFR 820.• Good knowledge in Statistical Analysis like ANOVA, Gage R&R using Minitab.

Chennai Area, India

• Designed equipment’s to match specifications; includes concept creation, detailed design, design calculations, manufacturing drawings, bill of materials, and product-related technical documents. • Established a design approach, estimate time for execution, and schedule the activities.• Developed manufacturing drawings in accordance with applicable standards.• Created Bill of Material (BOM) & preparing Product Technical Data Sheet.• Performed design calculation for the selection of components like Motor, Shaft, Gear, etc.• Manufacturing Drawing Creation for plate & sheet metal components.

Master Of Business Administration - Mba, Business Analytics

Bachelor Of Engineering - Be, Mechanical Engineering