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Medical Device Quality

Location:
Andover, NJ
Posted:
August 16, 2017

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Resume:

SAHIL CHAUBAL

Harrison, New Jersey. Phone: 757-***-****

Website: http://sahilchaubal.wixsite.com/resume Email: ac1uvw@r.postjobfree.com SUMMARY

A Biomedical and Quality Engineering professional with experience supporting the global medical device industry.

Medical device technician across many hospitals.

Researcher experienced in Laboratory Research and technical writing.

Experience with quality management system, risk management, and product complaint assessments.

Knowledge of FDA and CE medical device requirements related to post market medical device reporting

(MDR) to improve product quality, reliability, and safety. EXPERIENCE

GE (General Electrics) Healthcare April 2017- Present Biomedical Technician II

Manhattan, New York.

Quality assessment of medical equipment in hospitals with regard to their unit performance and other safety features.

Calibrating and performing maintenance tests as per OEM guidelines.

Determine the quality metrics in regards with customer complaints for the entire region of New York.

Evaluated biomedical equipment issues and implemented appropriate repairs.

Perform Preventive Maintenance and safety inspections and maintained effective customer relations.

Establishing and engaging in proactive daily communications with customers, to ensure resolution and proper follow-up, leading to strong customer relations and customer satisfaction.

Worked as a team to provide efficient service delivery to all accounts within the assigned area.

Document all repair actions and submit reports/summaries per schedule. Neuroscience Engineering Speech and Hearing Laboratory Dec 2016 – March 2017 Research Assistant

Newark, New Jersey

Conducted experiments on Gerbils to acquire intra-cortical neural signal from auditory cortex using micro- electrode.

Applied different Signal processing algorithms to decode the brain activity from the electrophysiological signal.

Derived Spike sorting using Machine Learning techniques to reveal neuronal firing patterns.

Denoised the collected data with Signal Detection Theory.

Application of Statistical analysis to derive conclusion on the study.

Sound calibration across the auditory booth used for sound isolation.

Design of experiments methodologies related to human auditory experiments.

Conducting experiment trials on human subjects for determining the hearing threshold and Inter-aural time difference

Assisting in research and technical writing for conference presentation, paper publication and grant proposals. Hospitech July 2012 – August 2015

Quality Engineering

Mumbai, India

Set up and implemented the Quality Management System (QMS) in compliance with ISO 13485 for medical device manufacturing.

Collected, analyzed, and implemented KPI (Key Performances Indicators) to ensure adherence with quality metrics.

Gathered, analyzed, and assessed customer product complaints using Electronic Medical Records (EMR).

Analysis of quality data for trending purposes using software tools such as MiniTab and Microsoft Excel. Preparation of QA reports

Conducted root cause analysis and statistical analysis to identify trends and report serious issues.

Implemented Risk Management system according to ISO 14971.

Performed risks assessments related to product manufacturing.

Identified and reported Corrective and Preventive Actions (CAPAs) to the manufacturing team.

Wrote SOP (Standard Operating Procedures), quality templates, and regulatory forms according to the organizational policies.

Trained manufacturing team according to ISO 13485.

Provided support in preparing for CE and FDA audits and executing audits.

Conducted audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions.

Conducted Design and Development activities from design inputs till design validation stage for Anesthesia Workstation.

Quality head for new product development, starting from survey till packing.

Gained knowledge of CE and FDA medical device requirements related to medical device reporting (MDR) to improve product quality, reliability, and safety.

Assessed the risk associated to manufacturing of Anesthesia Machine and successfully implemented Risk Management system according to ISO 14971.

Achievements: Acquired CE (Conformité Européene) marking for the company.

Review and evaluation of incoming inspection assigned non-conformances, ensuring prompt feedback. RESEARCH

Conducted experiments on gerbils (Rodent) to find auditory behavior in humans, finding intra-cortical firing pattern in gerbils which shows a correlation with the hearing capability in normal hearing and hearing deprived gerbils (Thesis).

Used fNIRS (Functional Near Infrared Spectroscopy) to map the secondary auditory cortex for sound localization and memory load using Signal Processing and Machine learning techniques.

Performed Brain Tumor detection (fMRI) on human scans using statistical software.

Sleep cycle detection in human with EEG using signal processing techniques. EDUCATION

Masters in Biomedical Engineering, New Jersey Institute of Technology Master’s Thesis: “Denoising Techniques Reveal Neural Correlates of Modulation Masking Release in Auditory Cortex”.

Bachelors in Biomedical Engineering, Mumbai University PUBLICATION

Ihlefeld, S.S. Chaubal, M. Ning, N. Alamatsaz, (2017). Neural Correlates of Modulation Masking Release: The Role of Sound Deprivation. The Journal of the Acoustical Society of America.

Conference publication of “Denoising techniques reveal neural correlates of Modulation Masking Release” in North-East Bioengineering Conference, In New Jersey Institute of Technology. SKILLS

Software: MATLAB, Python, SAS, LabVIEW, SQL, Solidworks, Linux, AutoCAD, HTML, MS Office and Photoshop.

Other Skills: Quality Management System, Statistical Process Control (SPC), Machine Learning, Data Mining, Medical Device Handling, and EMR (Electronic Medical Record). ACHIEVEMENTS

Nominated as a best researcher for Dana Konx award from New Jersey Institute of technology.

Defended Master’s Thesis and Publication

Chairperson (Student Wing), IEEE, EMBS



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