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Medical Engineer

Location:
Salt Lake City, UT
Posted:
December 29, 2018

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Resume:

Shruti Shukla

• Buffalo, NY *****716-***-**** • ac72ut@r.postjobfree.com • /in/shrutishukla1

PROFESSIONAL EXPERIENCE

Graduate Research Assistant

Canon Stroke and Vascular Research Center January 2018 Present, Buffalo, NY, USA Investigation of Ultrasound Contrast Media

• Processing of 3D-printed patient specific vascular phantoms from CT data (Stratasys EDEN 3D printer).

• Quantification of flow rates through Power Doppler (Canon Ultrasound Unit).

• Development of a multi modal contrast agent and comparison of flow rate measurement with DSA parametric imaging and ultrasound by means of a flow loop (Canon-Toshiba Infinix Angiography system). Biomedical Engineer

Meditech Electronics Lab September 2014 May 2017, Lucknow, India

• Collaborated successfully with cross-functional development teams to design and manufacture products, following Safe Medical Device Act (SMDA) and FDA guidelines.

• Utilized ISO 13485 standards to ensure the consistent design, development, production, installation, and delivery of medical devices.

• Designed test plans, test reports & wrote qualification documents following ISO 9000 for quality assurance purposes.

• Improved quality processes using DMAIC strategy to reduce the amount of wasted time and resources, thereby increasing organization’s productivity.

Biomedical Trainee

Meditech Electronics Lab July 2013 August 2014, Lucknow, India

• Design and develop new products as well as product changes and enhancement, which are consistent with a zero defect level as well as low product cost, following Quality System Regulations (FDA 21 CFR Part 820).

• Create assembly and Layout drawings using SolidWorks technology and CAD for instrumentation of Products.

• Follow ISO 17025 standards for equipment testing & calibration and timely monitor contract services viz. A.M.C. and C.M.C.

• Recognized by supervisor as going "above and beyond", earning a 98% performance rating as a Lead Trainee. Biomedical Intern

Max Super Specialty Hospital June 2012 August 2012, New Delhi, India

• Diagnose malfunctioning equipment and service them to maximize up-time with attention to safety, quality and compliance issues.

• Create test plans, collect test data, analyze results, maintain accurate documentation of concepts and perform all product development activities in compliance with hospital’s quality system.

• Use DBMS to minimize data inconsistency and keep track of inventory requirements as well as maintain equipment history. PROJECTS

Instrumentation for Midline Deviation Rectifier (AutoCAD, Fritzing)

• Designed a wearable belt to detect and rehabilitate the deviation in the normal human stance/gait within FDA guidelines.

• Achieved almost perfect natural human gait for patients trying to recover post stroke. Installation & Delivery of an Advance Modular Operation Theater (CE/US marked, FDA, ISO, AERB standards)

• Identified critical design requirements, performed failure safe analysis & built a modular OT for Star Hospital, Kathmandu, Nepal. Implementation of a Medical Gas Pipeline System (Pipe-BS 5750 quality assurance certification, BSI marked)

• Designed a central system with gas specific terminal units that only accepts the correct medical gas probe.

• Ensured easy, accurate and low cost installation & reduced maintenance time. EDUCATION

Master of Science in Biomedical Engineering, University at Buffalo, Buffalo, NY June 2019 • 3.4 GPA Bachelor of Science in Biomedical Engineering, Uttar Pradesh Technical University, India June 2013 • 3.7 GPA PUBLICATIONS

• Microchips – A Leading Innovation in Medicine [https://ieeexplore.ieee.org/document/7724256]

• Approaches of Artificial Intelligence in Biomedical Image Processing [https://doi.org/10.1109/ICACCA.2016.7578900] CAMPUS INVOLVEMENT

Vice President, Biomedical Engineering Graduate Student Association Club August 2017 Present

• Raised funds through involvement with career services on campus and conducted industry batch tours & workshops. Secretary-Media & Publicity, ABHYUDAY- College’s official & technical Forum September 2009 June 2013

• Established relations & communications outside campus with cultural and social groups to organise and sponsor events. SKILLS

Working knowledge: cGMP • FDA regulations 21 CFR 820 • ISO 13485 • ISO 17025 • ISO 9000 • CAPA Tools: Excel (VBA) • AutoCAD • Minitab • LabVIEW • SolidWorks • MATLAB • Python Data Analysis & Visualisaton Reliability Techniques: Six Sigma • FMEA/FMECA-Risk Management Analysis • 3D Printing



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