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Engineer Quality

Warsaw, Indiana, United States
May 01, 2019

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HIRAL PATEL, *24 Lakeland Dr, Warsaw, IN 46580, 682-***-****,


Six Sigma Green Belt (SSGB) Certified Biomedical Engineer, driven by innovations in biomedical engineering, seeking to pursue a career in a medical device and healthcare industry.

Experience with working in ISO 13485, ISO 14971 and 21 CFR 820 environment

Worked with cross-functional teams to support design quality assurance documents

Familiarity with electronic instrumentation, statistical analysis, and data processing

Provided quality design assurance support for maintaining design history files (DHFs)

Experience in driving design reviews, device performance reviews

Evaluated DFMEA, UFMEA for product features and specifications

Reviewed and Approved Design Verification and Validation protocols and reports

Experience with geometric dimensioning and tolerancing (GD&T)

Experience with Engineering Software’s: Minitab, R software, Team center, Lotus Notes, Plot view, and ROBAR.

Expertise: Statistical Analysis, Project Management, Quality Assurance, Product Verification and Validation, Electronic Document Management, and Regulatory Submissions

Documentation Tools: MS Word, Excel, Outlook, PowerPoint, Adobe Acrobat Reader, and Standard Office Tools.


Quality Engineer

Zimmer Biomet, Warsaw, Indiana Jan 2018- Present

Assisting with the remediation and restructuring of the design control documentation of orthopedic implants and instruments

Contributes in design review to confirm quality initiatives as a team with cross-functional working group including Regulatory, Development Engineer and Independent reviewer

Approving Engineering justification memorandums, existing verification documents, verification reports and technical protocols as per the ISO, ASTM and FDA guidelines

Evaluate DFMEA and UFMEA for implants and instruments product families

Creating and performing design verification and validation reports for implants and instruments

Perform statistical analysis using Minitab to verify the number of the samples/specimens to be used for the physical testing of the implants or the instrument

Reviewing Test Method Validation for the mechanical testing of implants/instruments.

Reviewing parameters for the physical testing such as the acceptance criteria, method used as per ISO or ASTM standard, test part equivalency and worst-case selection of the test specimen among the different sizes available in the family (DHF) of the implant or instrument

Lead approver on change management requests on design review documentation

Quality System Regulations(QSR) 21 CFR Part 820, ISO 13485, ISO 14971, ANSI/AAMI ST77:2013, HE75:2009

Lead and mentor fellow Quality Engineers

Biomedical Engineering Intern Jun 2013-July2013

Sterling Hospitals, Ahmedabad, India

Developed and updated evaluation report for performance reliability for medical devices.

Identified and ordered and tracked medical devices required for operating rooms at the hospital

Promptly grasped the knowledge of the working principle, mechanism, and physics behind the modality design.

Assisted senior biomedical engineers with the calibration and maintenance of medical devices as well as in preparing documents.


University of Texas at Arlington

EOG based eye movement measure of visual fatigue caused by improper sleep

Designed and Implemented an Eye Fatigue measurement system using BIOPAC by tracking the eye movements under various activities which involves rapid eye movement.

Implemented on Insomniac and healthy subjects and the results were statistically analyzed using statistical software to validate the data and interpretations to study the eye fatigue level.

Auditory Assessment based on EEG using LabVIEW

For auditory assessment in the case of elderly people and infants, they won’t be able to provide any substantial response to the stimulus and in the other case which is of mentally challenged patients; they won’t be willing to give the screening test. Thus, this project helps in reviewing another means to detect the auditory loss so that early and accurate diagnosis is possible.

Analyzed an Auditory evoked potentials (AEP) in the background EEG and plotted an audiogram of the subject for the purpose of diagnosing the subject for a hearing related disorder in real time.


Human Brain and Behavior

Tissue Ultrasound Optical Imaging

Selected Topics in Bioengineering- MATLAB

Human Physiology in Bioengineering


Medical Imaging

Tissue Optics

Laboratory Principles

Biomedical Optics Laboratory

Selected Topics in Math- Statistics


Master of Science (MS) in Biomedical Engineering (GPA: 3.7) Aug 2015-May 2017

The University of Texas at Arlington, Dallas, Texas

Bachelor of Technology in Biomedical Engineering (GPA: 7.5/10.0) Aug 2010-May 2014

Minor: Instrumentation

UVP College of Engineering, Ganpat University, Mehsana, India


Six Sigma Green Belt- Management and strategy Institute


Willing to relocate for the better opportunities.

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