PAVAN K

https://www.linkedin.com/in/pavan-k-mech/

Cell: 616-***-**** Moretti Dr, Concord, CA-94518 Email: adikg2@r.postjobfree.com

PROFESSIONAL SUMMARY

Detail-oriented System Verification Engineer with experience in new product development, design verification and validation (V&V), R&D activities in Medical Device.

+2 years of Design/Manufacturing experience and Certified in SolidWorks CAD software and Lean Six Sigma Green Belt.

Professional experience in Design Verification and Validation activities, modifying System Requirements and conducting root cause analysis, DFMEA in New Product Development (NPD) environment.

Highly skilled in creating Test Methods, Test Protocols, and writing technical reports as FDA regulations.

Experienced in Continuous Improvements (CI), CAPAs, cGMP, and GDP regulations, statistical process control (SPC), MSA, DOE, IQC and, Lean Six Sigma manufacturing.

Working knowledge of FDA & Quality System Regulations (QSR) 21 CFR Part 820/11, ISO 13485/14971 standards.

EDUCATION

Master of Science in Mechanical Engineering - Fairfield University Jan 2017 – Dec 2018

Bachelor of Mechanical Engineering - Jawaharlal Nehru Technological University May 2013 – May 2016

TECHNICAL SKILLS

Software: SolidWorks, CREO/Pro-E, AutoCAD, ANSYS, MATLAB

Statistical Tools: Minitab

Basic Competencies: FMEA, GD&T, Microsoft Excel, DFMEA, EU MDR

Certifications: SolidWorks (CSWP), Autodesk Fusion 360 Integrated CAD/CAM/CAE, Lean Six Sigma Green Belt

Product data & life management Software: Windchill, AGILE, JIRA, DOORS, HP ALM

WORK EXPERIENCE

Client: Fresenius Medical Care (FMC), Concord, CA Dec 2019 – Present

Role: System Verification Engineer (Infusion Pump, Peritoneal Dialysis Machine)

Working in new product development team, developing test methods/protocols for a complex electromechanical device to conduct Design Verification and Validation (V&V) activities as per 21 CFR Part 820 FDA regulations.

Performing unstructured testing and troubleshooting electronic circuitry, hydraulic and pneumatic systems.

Analyzing the collected data in Minitab (Statistical Analysis), gauge repeatability and reproducibility (Gage R&R), Confidence and Tolerance intervals, Individual Value Plots, to verify the system requirements.

Authoring engineering technical reports followed by Good Documentation Practices (GDP), routing documents in AGILE (PLM).

Performing mechanical design verification testing (MDVT) and electrical design verification testing (EDVT) to evaluate new and existing products.

Used various lab equipment’s for testing such as Pressure Sensor, Air compressor, Pumps, Temperature Probes.

Designed various fixtures as per the requirement using SolidWorks and generated 3D modeling and 2D- engineering drawings as per GD&T (ASME Y14.5 1994) drafting standards.

Documenting master deviation & defects report, validation summary reports and requirement traceability matrix.

Good Documentation Practices (GDP), Interpreting and analyzing various Engineering Diagrams, BOM’s, Part/Assembly Drawings for Quality Engineering reports for audit purposes.

Validating systems in compliance with the Quality Management System (QMS), Product Life Cycle (PLM), and all associated Standard Operating Procedures (SOPs) as per FDA Regulations.

Investigating corrective actions (CAPAs) and Root Cause Analysis, risk management.

Providing assistance to junior technicians with more complex support tasks that require a higher level of understanding of functions.

Client: Medtronic, New Haven, CT Feb 2019 – Nov 2019

Role: System Test Engineer (Minimally Invasive Surgical Robots)

Worked in a multi-disciplinary team, developed test protocols for a Class III Medical Device (Minimally Invasive Surgical Robots).

Executed & validated about 30 test protocols, to analyze the performance of the robotic system which involves the usage of various mechanical fixtures, force sensors, highly sensitive optical trackers collected data.

Summarized the results from multiple experiments into an engineering technical reports in JAMA and provided statistical analysis (Minitab) for all verification level tests.

Assisted with the maintenance of the Electronic Document Management System (EDMS).

Provided input to the test development team to assist in the development of test protocols and prototype builds.

Operated various lab equipment’s for reliability testing such as Instron mechanical testers, universal tensile testing machines, autoclaves, Scanning Electron Microscope (SEM), force gauges, imaging scopes, oscilloscopes, data loggers, oscilloscopes, pressure and flow gauges, sound level measuring equipment, and other equipment.

Handled a wide range of high capital, electro-mechanical testing equipment like CMM and universal robots UR5.

Ensured calibration, preventative maintenance, and proper operation of laboratory equipment.

Communicated test-related activities and results with multi-disciplinary team members.

Served as an extended team member for engineering team meetings.

Maintained content and traceability evidence of System Requirements, in the DOORS.

Trained operators to appropriate SOPs in adhere to safety policies and procedures.

Swarm Robotix, Nokia Bell Labs, Naperville, IL May 2018 – Aug 2018

Role: Mechanical Engineer (Intern)

Worked with R&D team for a new product development project MacJac (Mobile Autonomous Container Jack) and designed the CAD models in SolidWorks for Chassis and Swerve drive.

Conducted DFMEA and performed FEA (ANSYS) on lift-mechanism for MacJac. So, it could lift a 1000 lbs. container, within the project budget & lead time.

Brainstormed about the automatic twist lock mechanism, 3D printed prototype for design conceptualization and realization.

Machined parts on the lathe, milling, CNC machines as per the requirement for the robotics solution.

Fairfield University, Fairfield, CT Jan 2017 – Dec 2018

Role: Graduate Assistant

Conducted research and field testing on plastics, steel material used for advanced manufacturing.

Designed Tissue Scaffold structures using SolidWorks (CAD) and implemented cost effective techniques and fabricated a prototype using Additive Manufacturing (3D Printing), Laser Machining and Ultrasonic Cleaning with high precision levels.

Conduced DFMEA and Finite Element Analysis (Stress/ Strain / deformation) simulation for structural stability and thermodynamics properties by using ANSYS.

Conducted Mechanical testing (destructive) using Instron Universal Testing Machine and Rockwell Hardness on Polymers to determine their Mechanical Properties.

Analyzed porous structure with image characterization using Scanning Electron Microscope (SEM).

Teaching assistant for the course Applications of Robot Kinematics, assisted under-graduate students in robotics lab to conduct forward kinematics, DH convection and inverse kinematics experiments on Rhino XR robotic arm.

Teaching assistant for courses heat transfer and thermodynamics.

PROJECTS

Fairfield University, Fairfield, CT Jan 2017 – Dec 2018

Failure Analysis of a Plastic Chair - Fracture Mechanics

Analyzed mechanical failures based on the fracture surfaces by means of Scanning Electron Microscope (SEM).

Tested the material properties using Instron, identified the crack origin, direction of crack growth and mode of failure.

Designed a 3-D Surface model of chair, performed FEA using ANSYS workbench to compare experimental and analytical data.

3D Solid Modelling Design and Analysis of Rappelling Attachment Lug

Designed CAD model using SolidWorks and performed FEA, utilized material database tools to analyze potential materials for design optimization.

Modified model geometry for analytical accuracy vs. computational time, considered bearing and transverse loading scenarios of different variations of design choice and optimized the model for lowest weight, considering material yield conditions, factor of safety and margin of safety.

Design and manufacturing of Tissue Scaffold for Drug Testing

Designed scaffold structures in SolidWorks and researched about bio-compatible & bio-degradable materials that are suitable for the development of scaffold and chosen PLA and 3D printed using Maker Bot 3D printer.

Design and Fabrication of Stewart platform - Mechatronics

Designed a Stewart platform using SolidWorks and fabricated the prototype of Stewart platform.

Utilized Arduino to control servo motors responsible for moving the Stewart platform in all 6DOF.

Application of Robotics

Project description Assembled the components of Rhino XR-3 robotic arm and control the robotic arm with a teach pendant.

Performed Forward Kinematics, DH convection & Inverse Kinematics on Rhino XR to compute position of an end effector, compared measured data to find the precision and accuracy of a robot.

Thermal Analysis on a Heat Sink

Designed a heat sink used for Intel Pentium III processor (Socket 370) and performed thermal analysis to study the heat flow characteristics of both Forced and Natural convection using SolidWorks.

Optimized the output temperature by making changes in design and input parameters by considering thermal design power and case temperatures.

Lean Six Sigma Project – Sodexo

Conducted a Root Cause Analysis to eliminate waste, reduce waste walk and maximize the efficiency.

Implemented Two-Bin Kanban, JIT, and 5S Lean Six Sigma concepts, thus, reduced the TAKT Time resulting in a 23% increase in efficiency. Maintained the inventory as per the demand using Kanban Chart that reduced the costs and improved the quality.

LEADERSHIP EXPERIENCE

Graduate Student Service Award for Commitment and Service to Fairfield University.

Led the team for Connecticut Innovation Challenge 2018 and accomplished 1st place with $1000 reward.

Achieved 1st place in ROBO WARS Competitions using remotely-controlled robots (Team Lead).

Prosthetic Hand 3D Printing Project, Biomedical Engineering Student Society, Fairfield (Student Mentor).

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