Ninad Khade

A passionate Mechanical Engineer with the objective of improving everyday engineering challenges with problem-solving, cost-effective methods and solutions. Enthusiastic person ready to team up to work towards achieving desired business goals. Possess strong engineering aptitude with willingness to learn new tools and techniques, and lead value adding projects to deliver results.

Manufacturing Engineer II | Boston Scientific Corporation | Maple Grove, MN, USA                            Aug 2022-Present

• Manufacturing Line Support
  • Owning multiple manufacturing production lines, processes, and equipment for Interventional Cardiology catheters.
  • Hands on experience with manufacturing technologies like Laser welding and printing, Polymer Reflow. 
  • Sustaining and improving manufacturing yield outputs by utilizing RCA and Problem-solving tools for investigations and issue resolution.
  • Collaborating actively with cross functional teams like R&D, DQA (Design Quality Assurance) and SQA (Supplier Quality Assurance) for everyday quality issues and potential technology changes.
  • Responsible for ensuring compliance of the design control process to CFR and ISO requirements pertaining to the design of spinal implants and instruments.  
• Continuous Improvement Projects
  • Lead laser welding yields improvement project utilizing Problem solving roadmap (DMAIC) to recover scrap loss and stabilize laser welding process. 
  • Implemented global quality system initiatives for continuous improvement of product design, lean manufacturing and supplier quality that enhanced product quality, reduced cost, increased yields and operational efficiency using empirical tools such as: DMAIC, VOC, DRM, DFA, DFM, Quantitative Risk Analysis, FTA, Root Cause Failure Analysis, Design Requirements, VOC, dFMEA's, pFMEA's, TMV's, DOE's, SPC, Statistical Analysis, ANOVA, Gage R&R, 3D CAD, FEA, Simulation Modelling, GD&T, Artificial Aging, Life Cycle Testing and IQ/OQ/PQ, for design, build and test of complex medical devices, electro-mechanical systems, components, precision tooling and fixtures
  • Identifying opportunities to optimize product flow and mitigate bottleneck processes by evaluating Work Content Graphs. 
  • Practicing and promoting use of Six sigma and Lean manufacturing tools like Kaizen, 5S/Visual management, Waste Walk/Gemba to determine potential improvement opportunities.
• Line move
  • Collaborated in Kaizen event for brainstorming, assessing, and finalizing optimum product, material, operator flow and space utilization.
  • Assessed requirements for mobile and non-mobile equipment for calibrations and qualifications; requested calibration updates and performed post move qualifications. 
  • Co-ordinated with cross-functional teams like utilities and IEs for line moves while promoting efficient use of resources, material, and space.

Boston Scientific Corporation

Manufacturing Engineer II 

Maple Grove, MN, USA                                                                                                             Oct 2019-Jul 2022

Worked primarily on Manufacturing processes and process controls for Thrombectomy PI & IC catheters under Remediation project involving intensive PV&V activities (OQ/PQ and TMVs), Global Risk documentation conversions and Process improvements.

• Remediation
  • Assessed and remediated gaps in documentation for Process Validation and Verification, Tool Qualifications and Risk documentation to be compliant to company QMS and be audit ready per FDA standards.
• Process Validation and Verification (PV&V)
  • Evaluated process outputs requiring PV&V documentation, researched historical validation data and lead OQ/PQ, ATMV, VTMV, Gage R&R studies, and Inspection improvements activities.
  • Identified Key Process Inputs (KPI) towards associated process outputs by studying and analyzing the manufacturing process, equipment, labour, and other potential factors contributing to process variation.
  • Collaborated with cross-functional teams- R&D for accurate product specifications, Production for SWR Runs/ATMV executions, Product Assurance Lab for testing and PV&V SMEs.
  • Performed Process Capability Analysis using Minitab and company approved Statistical data analysis tools, authoring PV&V Protocols and Reports, and resulting change documentation.
• Process Improvements and Streamlining
  • Assessed impact of procedure consolidations and improvements on MES (Manufacturing Execution System) documentations and Process Plans; coordinated with MES team for smooth implementations avoiding downtimes.
  • Created and updated new Visual inspection aids like Visual Standards (VS) and trained operators to them. 
  • Developed fixture for reducing scrap using modern manufacturing and prototyping method like Additive manufacturing. 
• Risk Management
  • Structured and updated the Master Validation Plan (MVP) and Process Risk Analysis (PRA)/ Process FMEA documentation with Validation and Verification Report and print control references.
  • Partnered in discussions and decisions with Regulatory team for changes to existing and potential new inspections for class II and class III devices which could trigger a Regulatory submission and implementing appropriate updates to minimize impact.
• Product Transfer
  • Managed multiple product families and related manufacturing processes by sharing knowledge and product experience with cross-site teams.
  • Co-ordinated between product sending site and receiving site about aligning PV&V activities, Tool qualification/ Calibration statuses, manufacturing procedure cross-site requirements and documentation approvals.

Zimmer Biomet

Manufacturing Engineer                                                                                                           Dec 2018-Oct 2019

• Administered day-to-day Manufacturing and Quality matrices, assessed and fixed problems for maximum yield and scrap reduction for class III orthopedic implants.
• Lead the advancement, usage, support and constant change of manufacturing procedures, tools, apparatuses, and investigation to build proficiency, adaptability, creation, quality and reliability of existing items.
• Worked on Product Manufacturing Transfer, Process Development, Extrusion/ Injection/ Insert Molding
• Lead group in performing risk analysis, root cause analysis of non-conforming product, in concert with other departments; including identification and recommendation of corrective and preventive actions resulting from product evaluation activities.
• Improved processes and efficiencies working with suppliers on Test Method Validation procedures (TMV); reviewing/approving supplier testing results for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) which includes closing validation deviations. Created RM Plan / RM Report ensuring compliance with QSR 820 and ISO 14971
• Identified and analyzed losses and develop solutions and control plans using Lean Tools such as 5S, 5W, Bottleneck Analysis, Gemba, Kaizen, Kanban, KPI (Key Performance Indicators), Poka-Yoke, SMED, Value Stream Mapping, Visual Factory, Standardize Work, Takt-Time, Statistics tools, Control Charts, Pareto and FMEA, etc.
• Performed timely Preventive Maintenance (PM) on equipment like lathe, ultrasonic washers, tracked calibration status and calibrated various tools and measurement systems like Co-ordinate Measurement Machine (CMM).
• Designed Test fixtures and assemblies using SolidWorks, and Geometric Dimensioning and Tolerance (GD&T) under ASME standards. 
• Closely worked with and assisted Engineers in DOE, PV&V activities, TQs, In-Process Monitoring (IPM) activities and documentation creation of Protocols, Visual aids, and manufacturing procedures. 

Tesla Inc.

Production Associate | | Gigafactory 1, NV, USA                                                                          Aug 2018-Nov 2018

• Performed variety of operations, including assembly, troubleshooting and quality inspections of sub-assemblies and full unit assemblies of complex electromechanical components.
• Followed and promoted GMP and GDP to standardize Quality first culture improving work efficiency and traceability.

Actively used MOS- a Tesla developed Inventory management software used for inventory managing and monitoring task like put-away, move, deliver, transfer container, loop status etc. for a heathy inventory and smooth product flow

Master of Engineering in Mechanical Engineering