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SUMMARY
A Biomedical Engineering Analyst with experience supporting product development and also bring
customer satisfaction for clients of Healthcare organizations.
Maintain the professional competence, knowledge and skills necessary for the satisfactory
performance of all assigned responsibilities. Conduct statistical, trending and variance analysis.
Participate in inspection trials; analyzing product dimensions, reliability, material costs, trends,
variances, and improvement opportunities through Minitab.
Strong technical writing skills with experience delivering weekly technical reports including technical
methodologies, formulations, statistics, testing results, and summaries.
Expertise in signal processing, image processing, and quality assurance.
Self-motivated, Team player and detail oriented.
SKILLS
Lean Six Sigma Green Belt Certified. (ISCEA Certificate # 251-3151)
Direct experience in development of externally-worn medical devices
Programming languages: C, C++, Java, Python, Linux
MATLAB, LabVIEW, Solid Works, Minitab, KEIL, NI Multisim, ImageJ, Solidworks
Proficient at Microsoft Word, Excel and PowerPoint
Strong technical writing and communication skills
Understanding of Lean Manufacturing and DOE.
Familiar with FDA and ISO regulatory standards
EDUCATION
M.S. in Biomedical Engineering - University of Texas at Arlington, Texas
B.E. in Biomedical Engineering - University of Mumbai, India
Relevant Coursework: Digital signal processing, Ultrasound Optics, Bio-instrumentation, Biomedical Optics,
process control, biomedical imaging, statistical analysis, Human Anatomy and physiology.
Seminar: Attended Non-Destructive Failure Analysis seminar organized by ASQ Biomedical Division DFW
Discussion Group in September, 2015.
WORK EXPERIENCE
Engineer Degreed I July2015-Present
Abbott Diagnostics Division, Quality Systems
Extensive knowledge of change control, design control, design verification while working on the new
product of Abbott.
Working on product lifecycle management database software for Quality check on parts of new product as
required by FDA.
Checking on the compliance of the parts involved in the process of product development dealing with
21CFR 820, QSR and ISO 13485:2003.
Maintain DHF and update it at the end of every major phase of the product life cycle.
Provide guidance in the interpretation of design and development plan.
Approve product design, process and equipment quality qualifications with the help of Change
control packages in PLM software.
Part of team handling transition of New Product into regular manufacturing phase abiding the rules
states by the FDA. Experience working in a cross functional team.
Comply with established practices, policies and documented procedures
Device for Post-detection of Epilepsy using EMG (Research Project Mumbai University)
Built a circuit using instrumentation amplifier and band pass filter. (Team Lead)
Signals extracted from muscles integrated with 18F2550 pic-microcontroller for the signal conditioning.
The output is interfaced with an alarm which will detect stroke in the patient.
Utilized Excel complex formulations to evaluate raw data and control groups to support hypothesis
testing and laboratory experimentations.