Engineering Engineer

***** ******* **, ******, ** - *****

E-Mail: *****.****@*****.*** Phone: 317-***-**** (c)

Summary

Medical Device Engineering professional with extensive communication and problem solving skills. Have excellent experience in Medical Devices, Software Validation, process equipment, laboratory instruments, Analyzers, Generating System and Subsystem level Requirements, Requirement Management using DOORs and Cockpit. Experience with various stages of the validation cycle such as cGMP assessments, risk assessments, writing and executing Validation Plans, FMEA, IQ, OQ, PQ, Documentation etc.

WORK EXPERIENCE

Feb 2010 – Nov 2011: Systems Engineer at Beckman Coulter, Indianapolis

• Successfully developed System and subsystem level Requirements for DXN project based on customer and business needs.

• Worked extensively on requirement management using DOORS and COCKPIT tools.

• Responsible for Risk assessment at various stages of the product development and creating risk management plans.

• Responsible for design output reviews documentation work for FDA approval.

• Created traceability matrix to ensure flow down of parent to child requirements.

• Hands on experience on running the instrument using real Assays and DNA for verifying instrument characterization.

• Performed system level and subsystem tests and analyzed run data for Failure rate analysis and made recommendations for design improvements.

• Responsible for writing and executing test plans at various stages including Preverification, Verification, Post Verification, and Validation efforts.

• Excellent hands on experience in troubleshooting instrument errors.

• Trained on Corrective and Preventive action (CAPA) to investigate, assess, resolve and document the actual system/process issues.

• Trained on Lean Six Sigma.

• Wrote hardware requirements for a module team and worked with design and development teams through developing manufacturing protos.

• Exceptional at schedule predictability and meeting commitments while achieving quality results.

• Exceptional at coordination while working with multiple groups.

Dec ’08-May ‘09: Biomedical Engineer Validation Documentation Specialist at Beckman Coulter, Indianapolis, IN

• Worked as Software Validation Documentation specialist.

• Responsible for Reverse Engineering Biomek Liquid handler System software Requirements.

• Prepared Software requirements and Product requirements for Biomek Liquid handler NX product as per Standard Operating Procedure (SOP).

• Worked on Documenting Validation Testing Summary Reports for existing Biomek software tests for ISO 9001 certification.

• Created Traceability Matrix to ensure flow down of requirements for Biomek NX

• Summarized Validation Testing Reports for existing Biomek software testings into a final report.

• Worked on Documenting Remediation Summary Reports.

• Worked extensively on DOORS for requirement management.

• Good understanding on Biomek Liquid handler Software, Hardware, and Labware.

• Responsible for preparing documentation work for FDA audit.

• Created DHF and index for the Biomek NX product.

Aug ’07 – Dec ’08: Validation Scientist at Roche Diagnostics, Indianapolis, IN

• Good knowledge and experience in Process Validation activities for IQ, OQ, and PQ in an FDA regulated environment.

• Excellent experience of following cGMPs/GLP and document writing for Validation.

• Extensively worked on Mass Spectrometers, HPLC, and PH meters.

• Good working knowledge on Instruments related to Analytical Chemistry and Clinical Chemistry.

• Extensively worked on Analyzers like Hitachi 917, Integra 800, Cobas Mira.

• Software programming for Instrument controllers attached to the Analyzers like Mass Spectrometer, Hitachi 917, Integra 800, Cobas Mira, and HPLC, for testing the reagents as per the operating procedures.

• Used mylab online for Scientific Data Management.

• Validation and Verification of the reagents for quality purpose for DAT’s (Drug Abusive Testing) and TDM’s (Therapeutic Drug Monitoring).

• Highly involved in reagent manufacturing and performance validation for the DAT and TDM reagents as per defined the protocols.

• Evaluated and reviewed the process to identify opportunities for increased efficiency in the Methods of Validation process.

• Trained on Report writing skills and documentation under FDA guidelines.

• Good working knowledge on Databases and Spreadsheets.

• Extensively used ANOVA techniques for Data analysis.

• Excellent skills in Titering reagents for DAT’s and TDM’s.

Aug ’01 – October 2003: Assistant Professor in Electronics and Instrumentation department,

Sir.C.R.R.College of Engineering, Eluru, India.

• Taught Instrumentation & Control Engineering, Electronics and Communication Engineering classes to undergraduate students with effective class success results of above 98%.

• Commissioned fully Automatic process Control Systems Lab with windows based software.

• Hands on experience on process control automation equipment such as flow control, level control, pressure control and temperature control modules.

• Good working knowledge of medical devices like ECG, EEG, EMG, Blood pressure monitoring, Blood flow analysis, Respiration monitoring instruments.

• Responsible for guiding students in performing lab work in Biomedical Instrumentation lab, Process control Lab, Electronics Lab, Microprocessor Lab, and Computer control process Lab.

• Taught various courses for B.S. Engineering Students

• Excellent hands on experience on digital and analog electronic devices such as - Linear IC’s, Instrumentation amplifiers, OPAMP’s, photo diodes, transducers, transformers etc.

• In-charge of Training and Placement department in College of Engineering. Conducted seminars, group discussions, coordinated Industrial visits, and workshops on personality development for students.

PROJECTS

• Designed and developed ‘Respiration Monitoring using Impedance Pneumography method’ to measure and monitor the respiration rate of the patient in order to diagnose any asthma problems using C++ and C graphics programming languages.

• Performed Systems Engineering studies - Did System Analysis, Validation and Verification aspects of a cardiovascular system design as part of Systems Engineering Studies.

• Developed a method for “PC based ECG analysis” to analyze the ECG waveform and diagnose various cardiovascular diseases like Arrhythmia, Tachycardia, and Atrial Fibrillation.

• Designed a test system to apply ocular pressures on trabecular meshwork cells to test new anti-glaucoma drugs.

• Designed a test system to conduct in vitro study of drug release kinetics of polymer coated drug eluting stents with variation in human body temperatures.

• Wrote a technical paper on “Drug Eluting PLGA based Tissue engineered heart valve”.

• Wrote a technical paper on “Development of high performance Stent Grafts for endovascular Therapy and other treatments” as a class project.

• Designed and developed “Heart rate variability Device” using Lab VIEW.

• Analyzed cardiovascular and Neurological Action potential data using MATLAB.

• Worked on various projects related to statistical hypothesis test, Anova analysis, and Student-T distribution testings using MATLAB as a part of class projects.

• Designed and developed “Blood pressure monitoring Device” using Cuff Pressure sensor and IR sensor.

CREDENTIALS

M.S in Biomedical Engineering (GPA 3.82/4.0) Purdue University, Indianapolis, IN (May 2008)

B.S. in Electronics and Instrumentation Engineering Sir.C.R.R.College of Engineering

(GPA 3.85/4.0) Eluru, India. (2001)

COURSEWORK

Biomedical Engineering Related Courses:

• Polymers for Biomedical Engineering Applications • Experimental methods in Biomedical Engineering • Systems Engineering • Advanced analytical chemistry • Biomaterials and neuroscience• Organic Chemistry • Clinical Chemistry • Tissue Engineering • Essential Cell biology • Molecular/Cellular Biomechanics • Bioinstrumentation • Biomechanics • Biomedical Instrumentation.

Electronics and Instrumentation Related Courses:

• Robotics • Electrical Machines •Electronics• Process Control • Fiber optics • Computer Control Process • Digital Signal Processing • Microprocessors • Digital Electronics • Industrial Instrumentation Design •Transducers • Linear ICs and Operational Amplifiers • Networks and Field Theory • Control Systems • Applied Mechanics and Strength of materials • Thermodynamics and Fluid Mechanics • Analog and Digital Communications• Telemetry and Tele-control.

SOFTWARE SKILLS

Programming Languages : C, C++, Pearl, LabVIEW, Matlab, FORTRAN, Solidworks

Microsoft Office : MS Word, MS Excel, Power Point, MS Access, MS Office

Operating systems : Windows, DOS

Software Tools : DOORS, COCKPIT, StarTeam, SQL, JMP

LAB EXPERIENCE

• Excellent experience on Analyzers like DXN, Smartcycler, Hitachi 917, Integra 800, Biomek Liquid Handler, Mass Spectrometer, Centrifuges, Cobras Mira, and Chromatography. Titering Reagents for DAT’s and TDM’s. Process Control Equipment, Biomedical Devices, Industrial Instrumentation Devices, Analog and digital Electronics Circuits and Microprocessors, Control systems Lab, Computer Control Process Lab.

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