Bhavin Khoda

ac6vy6@r.postjobfree.com

203-***-****

Education:

University of New Haven Graduated Dec 2017

Master of Science (M.S) Mechanical Engineering & Applied Mechanics

Key Courses: Engineering Design, Strength of Materials, Robotics- Kinematics & Design, Intermediate Kinematics, Advanced Dynamics, Advance Mechanics of Materials, Fundamentals of Finite Elements.

Gujrat Technological University, India Graduated July 2015

Bachelor of Technology (BTech) Mechanical Engineering

Gujrat Technological University, India Graduated May 2011

Diploma in Mechatronics Engineering

Summary:

•Experience with engineering design, design control in both engineering and manufacture departments.

•Strong technical writing skills having writing, test protocols, technical reviews, presentations, SOPs, study reports, nonconformance’s investigative reports, V&V reports.

•Implemented Failure Mode Effect Analysis (FMEA) for Risk Assessment.

•Knowledge of involving Validation Master Plan (VMP), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ).

•Experience in creating and reviewing Standard Operating Procedures (SOP’s)

•Reviewed and updated DFMEA, PFMEA, and risk analysis documents.

•Performed GAP analysis and remediation activities for a variety of medical devices documents.

•Expertise in problem solving techniques like Six-Sigma, Kaizen, 5 Whys, DMAIC.

•Strong skills with Risk Assessment, Corrective Action and Preventive Action (CAPA) investigation.

•Work independently to create process documentation including process flows, process inputs and outputs, process steps.

•Handled manufacturing and packaging of commercial batches.

•Hand on experience with tools like ANSYS, AutoCAD, SolidWorks, Minitab and GD&T.

Work Experiences:

Mechanical Engineer March 2018 - Present

Alpha Broader Prime Line Resources, Bridgeport, CT

•Developed and maintained independent project Quality System Plans based upon internal and client Standard Operating Procedures (SOPs) and reviewing Engineering documents.

•Apply knowledge of process control tools, statistical sampling, and other analytical techniques to maximize the quality and flow of product through the production line.

•Assisted in procedure development and maintenance, quality validation, including capability studies, verification and Gauge R&R, first article reports.

•Experienced using Oracle ERP system and able to prioritize the order as per requirements.

•Perform commissioning, qualification as well as validation of facilities, equipment, as well as utilities.

•Good understanding of – cGMP, GDP, Project Engineering, processing facilities, Process Equipment and Process Utilities for manufacturing plant.

•Participated in improvements activities and applying lean and six sigma methodologies.

•Handled Non-conformances and performed root cause analysis to resolve the issues.

•Managed continuous improvement projects with Lean Manufacturing Principles, S.P.C., and Kaizen Blitz events, which resulted in increase in the throughput, decrease in labor costs, and improved safety.

Manufacturing Engineer Oct 2017 - Dec 2017

Alpha Broader Prime Line Resources Intern, Bridgeport, CT

•Understand, plan and conduct Design of Experiments, Process Stability / Control / Capability methods, etc. for process characterizations/equipment development, setting parameters.

•Reviewed and updated DFMEA, PFMEA, and risk analysis documents.

•Developed process solutions by identifying, testing, and controlling factors that influence product performance and manufacturability.

•Write/update work instructions, part specifications, and various forms of reports.

•Interface with Manufacturing/Process Engineering, R&D, and Regulatory departments to resolve process issues and implement changes.

•Identify, analyze, and manage risk through product life cycle with use of FMEA and risk management tools.

•Experience with risk assessment, root cause analysis and writing investigation reports.

Manufacturing Engineer Jan 2014- May 2015

SKF Group, Gujarat, India

•Updated routers, creating Bill of Material (BOM), and inspection documents as per new improvement changes.

•Involved in preparing documentation for all aspects of the computer system validation lifecycle, including Installation Qualification (IQ) Specification, Operation Qualification (OQ) Specification, Performance Qualification (PQ) Specification.

•Managed SOP’s, Work Instructions and forms for new or revised products and processes.

•Executed line trials, Design of Experiments (DOE) and determine critical process parameters.

•Identified customer requirements, savings/improvement opportunities and solved challenging process-flow and resource-limitation problems.

•Designed work flow, space requirements, equipment layout to improve manufacturing efficiency.

•Applied Six Sigma principals to develop monitoring tools to enable cost reduction efforts.

•Worked with Manufacturing Engineers on process improvements to enhance and maintain high standards.

•Identified and implemented changes to reduce variation and improve scrap rates and productivity.

•Supported R&D, manufacturing, marketing, and customer service and suppliers.

•Documented the requirements for the installation of the device.

SKF Group, Gujarat, India June 2011– Aug 2011

Trainee Engineer

Investigated equipment failures to diagnose faulty operation and made appropriate maintenance recommendations.

Worked with manufacturing unit manufacturing bearing gaining practical knowledge of manufacturing process grinding, milling, turning and many more

Certification:

Six Sigma Green Belt by IISE April 2017

AutoCAD January 2011

Skills:

Responsible, Planned and organized

Auto-CAD, Solid-Works, ANSYS, Blueprint reading

5S, root-cause analysis, why-why,8D

MS office, SOP’s, Kaizen, FMEA

Strong verbal and written communication skills

Bill of Materials, technical report writing

ERP System- Net Suite, Continuous Improvements

Work instructions and documentation

Contact this candidate