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Medical Device Engineer

Location:
Plano, Texas, United States
Posted:
February 26, 2018

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ac4mft@r.postjobfree.com Khandan (Kandy) Khalkhali 972-***-****

Professional Qualification

Proven ability to successfully master new technology and contribute to delivering high quality healthcare through effective application and management of innovative healthcare solutions.

• Overall 2 years academic and industry experience in Biomedical Engineering/Medical device R&D, and Quality & Regulatory control

• Experience in implantable cardiac medical device and clinical support

• Specialized in the calibration, maintenance, refurbishment, test/inspection, and assembly of Neurology Diagnostic equipment

• Applicable knowledge of QMS, FDA 21CFR part 820, ISO 13485, ISO 14971

• Very strong laboratory research skills including executing experiments and data collection

• Documented, developed, and audited procedures and practices for QSR compliance

• Excellent Laboratory organization skills including project coordination and equipment maintenance

• Experience in engineering fundamentals, and medical device technology

Education

M.S. Biomedical Engineering University of Texas (Dallas) GPA 3.9 2014 – 2016(May)

(Member - National Honor Society)

B.S. Nuclear Physics Ferdosi University GPA 3.8 2004 - 2008

Relevant Training, Courses & Labs: Quality systems & compliance - ISO13485 and & 21CFR 820 (QSR)

Biomedical Micro Devices

Modeling & Simulation (biological process)

Clean Room

Standards & Regulations

Implants & Surgical Instruments

Self-assembly of Biomaterial

Audio-visual Presentations

Nanotechnology & Sensors

Human Anatomy and Physiology

Handled Equipment

Microwave plasma Chemical Vapor Deposition (MPCVD)

Scanning Electron Microscopy ( SEM)

Hot filament chemical deposition

Photolithography

Raman Spectroscopy

Academic Projects

Developed Quality Management System for Medical device to be marketed in US and European countries.

Authored Quality manual, Standard Operation Procedure (SOP), work instructions and forms for Labeling and Packaging control. Developed a correlation matrix and integrated same with other subsystems.

Carried out CAPA project on Heartmate ll LVAS recalls using Root Cause Analysis (RCA).

Carried out internal audit on complaint handling, Medical Device Reporting and risk management SOP as per QSR and ISO 14971.

Participated in FDA audit conducted by Roy Baby, Consumer Safety Officer of FDA by preparing and providing relevant documentation and analysis.

Developed MATLAB code to implement time delays associated with kinetics of chemical reactions using Gillespie’s stochastic simulation algorithm (GSSA).

Designed piezoelectric micro valve in micro-reservoir chips for treatment of disorders requiring chronic drug delivery to control release of rapid, small & discrete amounts of drug at distinct time points resulting in more accurate dosing.

ac4mft@r.postjobfree.com Khandan (Kandy) Khalkhali 972-***-****

Work and Academic Experience

Medtronic (contractor: Aerotek) Clinical Specialist December 2016 – Present

Provide clinical, technical and product knowledge support to existing and potential customers.

Serve as an effective Medtronic representative to physicians and support staff regarding Medtronic products, service and support.

Build and maintain solid customer relationships and provides customer training at all levels.

Represent Medtronic while conducting implantable cardiac medical devices sales/implants and providing clinical support in clinics.

Provide technical support in hospitals and clinics for products implantation and follow-ups by troubleshooting pacing system malfunctions, reprogramming, and providing product.

Updating the sales representatives about implants.

University of Texas (Dallas) Graduate Student Researcher Aug 2014 – May 2016

Gave direction and credibility to experiments by investigating several project topics using multiple resources including library and Internet databases, periodicals and published journal.

Provided hands-on, per-project performance experience by processing and analyzing data collected from experiments.

Helped to design portable devices & platforms for cellular & molecular diagnostics & therapeutics.

Developed and presented solutions and proposals to colleagues for health related products by assisting in development of ultrananocrystalline diamond (UNCD) thin film technology.

Conducted research on use of UNCD’s application in Ion-Lithium Batteries, Electronic Devices, Dental Implants, Dental Drills, and Hip Prosthesis.

Ion-Lithium Batteries:

Developed a breakthrough technology by growing robust ultrananocrystalline diamond (UNCD) films as coatings for the battery components such as anodes, cathodes, membranes for commercializing a new generation of Li-ion batteries (LIBs) with 10x longer life.

Electronic Devices:

Used the diamond films (UNCD, NCD and MCD) as the active material for the new generation of electronic power devices like TFT and Diodes, that can operate at extreme conditions such as high temperature and aggressive environmental.

Dental Implants and Hip Prosthesis:

Growth of the UNCD films to cover the Titanium hip implants and screws as dental implants and prevent the corrosion and infection generated by the etching of the Titanium surface by the body fluids.

Dental Drills:

Used the UNCD films to cover the conventional drills used for dental cleaning, to prevent the surface of the teeth become rough due to the roughness from the surface of the drill, and prevent the formation of bacteria.

Neuro Medical Equipment, Inc.(Texas, Arlington) Biomed Technician Aug 2014 – Nov 2016

Maintained and repaired/replaced equipment to ensure operating efficiency.

Participated in evaluation of new equipment/parts/supplies.

Office assistant for Neuro Medical Equipment, Inc. for Resolving customers' problems and issues through technical expertise and troubleshooting using service tools and manuals.

Documented medical equipment’s data for clinical effectiveness and reliability in a computerized maintenance management system (CMMS).

ac4mft@r.postjobfree.com Khandan (Kandy) Khalkhali 972-***-****

Redlined and/or developed service/ quality documents with assistance by senior professional.

Improved customer satisfaction by proactively advising and training them on the application and methods they were running to help them achieve improved scientific results and efficiency.

Core team member of Quality Improvement Patient Safety Team (QIPST). Presented monthly quality indicators and trends of Biomedical engineering department and assessed root cause analysis of the device failure.

University of Texas (Dallas) Teaching Assistant (TA) (Biomaterial) Aug 2014 – May2015

Graded homework, assignment and exams.

Collaborated with other TA’s and assisted professor in conducting exams.

Administered students in the absence of the professor and helped them solving problems in class.

Held office hours to tutor students.

Software Proficiencies:

Microsoft: Access, Excel, Outlook, PowerPoint, Publisher, Word, Windows

Other Software: Matlab, Comsol



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