Medical Device Engineering

YANIQUE SPIGNER

Paramus, NJ, *****

201-***-**** ● ********@*****.***

EDUCATION

Stevens Institute of Technology -Hoboken, NJ August 2019

Biomedical Engineering B.E.

Course Work:

Engineering Graphics (CAD design)

Biomedical Digital Signal Processing

SKILL

Programs: MATLAB, SolidWorks, LabView, Minitab

Languages: Python 3.0, C++, SQL

Technical: Soldering small components, create schematics, read schematics, basic electrical troubleshooting, 3D printing

EXPERIENCE

Quality Assurance Associate • Regi Laboratories U.S. Cosmetics • [West Caldwell, NJ] 2017

Created SOPs to establish company policy and procedure for manufacturing and safety on site including CAPA procedure for nonconformances and documentation

Led the validation for the production floor water system

Conducted an Internal audit to ensure compliance of ISO and FDA (21 CFR) standards for manufacturing

Ensured GLP, and GMP document compliance:

o created and implemented company procedure / appropriate documentation of the procedure

Determined sampling required for each batch produced on the production floor

Carried out, and documented laboratory tests to ensure the consistency of quality for products manufactured including products containing Active Pharmaceutical Ingredients (API)

Quality Control Technician • American Hygiene • [Clifton, NJ] 2014 -2015

Guaranteed quality of the product through visual and empirical analysis

Conducted lab tests on products to determine product specifications were met

oPreservative efficacy, pH, viscosity, emulsion stability

Maintained lab equipment

Performed clerical filing and organization

Academy Intern • Valley Hospital • [Ridgewood, NJ] 2012- 2013

Provided preventative maintenance and calibration for medical devices

Performed inspection and inventory for diagnostic, monitoring, and therapeutic instruments

Verified proper operation of diagnostic, monitoring, and therapeutic instruments

Pathology lab (Hematology, urinalysis, and biopsies) specimen handling, and initial intake

ACADEMIC PROJECTS

Stevens Institute of Technology

Senior Capstone Project (TrachAlert): Within my senior design team I was responsible for spearheading the design and preliminary testing protocol for both the circuitry and software of a medical device that monitors pediatric tracheostomy tubes. I created the logic of the medical device to allow it to continuously monitor several vital signs from the patient’s airflow and determine if the patient was breathing sufficiently. [Patent Pending]

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