Jainam Shah

Manufacturing Test Engineer

Personal Info

Address

**** * ****** **, *** # 233, Arlington, TX -

76010

Phone

682-***-****

E-mail

ac81u3@r.postjobfree.com

LinkedIn

https://www.linkedin.com/in/jainam-shah-

010753111/

Skills

MATLAB

advanced

Solid-Works

Intermediate

Python

Intermediate

R Programming (Statistical Tool)

Advanced

Problem Solving

Expert

Troubleshooting

Expert

Root Cause Analysis

Expert

CAPA Analysis

Expert

GLP, GMP, ISO, FDA (Standards and Regulations)

Expert

8D Problem Solving

Intermediate

Lean and Six Sigma

Advanced

DFMEA, PFMEA

Advanced

Medical Device Engineer experienced with Research and Development, Quality as well as Manufacturing Engineering at Industry Level.

• Completed a full course of Alinity S Service Training (Certified Service Engineer for Alinity S).

• Capable of handling multiple tasks simultaneously.

• Familiar with FDA and ISO Rules and Regulations.

• Capable of working as a single contributor as well as in a team.

• Sound knowledge of Lean and Six Sigma techniques, DFMEA, PFMEA. Experience

2018-04 -

present

Manufacturing Test Engineer

Abbott Laboratories

• Duties Include working on System Top level assembly as well as assembling different subsystems of the Instruments.

• Developed and implemented continues improvement techniques using Kaizen approach to reduce production time by 24%.

• Perform Root Cause Analysis and implement CAPA analysis to top-level assembly, sub- assembly, and factory testing.

• Hands-on experience in authoring and maintaining VMIs (Video Manufacturing Instructions), Manufacturing Processes, Test & validation Procedures documents.

• Experienced in documenting eDHR (Electronic Document History Record) and NCMR (Non- Conforming Material Reports) while system manufacturing and Factory Testing.

• Validating and verifying Equipment Qualification (EQ), Installation Qualification (IQ), Operation Qualification (OQ), Process Qualification (PQ) for new product release.

• Troubleshooting system errors using various test equipment (Torque Wrench, Fluke Meter, Hypot Tester, etc.)

2017-09 -

2018-04

System Integration Engineer

Abbott Laboratories

• Execute experimental protocols and PMS services on a highly complex medical system

(Alinity S) utilizing experimental techniques, theoretical models, and methods.

• Hands on experience in performing IQ, OQ and PQ on every new manufactured instrument.

• Efficient in evaluating technical documents, LOGs, result reports to promote preceding plans and continuous improvement schemes.

• Hands on experience in dealing with cross-functional team across the campus to get SME

(Subject Matter Expert) opinion to mitigate problem encountered in work process.

• Authored and Executed various verification protocols to verify hardware and software alterations and its impact on the performance of the instrument.

• Knowledge of safety standards, GLP, GMP, ISO, and FDA Regulations.

• Worked in R & D Lab which has maintained ISO/FSA Standards and been part of ISO audits.

• Performed Root Cause analysis and failure investigation on the instrument if breakdown reported.

• Hands on with Regulatory work needed for documenting reports, results, technical documents as per the standards and company policy.

2014-04 -

2015-06

Clinical Engineer

Healthcare Global Enterprise Ltd.

• Maintaining proper and accurate working of biomedical equipment.

• To meet the requirement of every surgeon by providing or arranging equipment according the requirement and need of the surgeon.

• Experience in performing and making monthly, quarterly or half yearly preventive maintenance service report documents to prevent any failure in functioning of biomedical equipment.

• Solving problem encountered in any machine as soon as possible.

• Over 1 years of experience with radiology medical devices (X ray, CT, MRI, Ultrasound).

• Monitor and Calibrate daily, weekly, and monthly working status of each machine.

• Quality control by inspection.

• Responsible to maintain accurate working of all operational and critical care equipment.

• Making Monthly, Quarterly and, Half Yearly Preventive Maintenance Report.

• Supervising and Maintaining Medical Gas Supply System. Education

2015-08 -

2017-05

University of Texas at Arlington

M.S. in Bioengineering - 3.70

2009-08 -

2013-05

Gujarat Technological University

B.E. in Bio-Medical Engineering - 3.50

Certificates

2018-02 Alinity s Series Service Curriculum

Academic Projects

2017-05 Effect of BIS Concentration on Temperature Sensitive PNIPAAm Hydrogel 2016-12 Analysis of High Dose Intravenous Noloxone Data using R programing 2015-12 Segmentation using MATLAB to isolate intracranial brain disease tissue

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