Zakia Mizan
Bedford,TX
Summary
Technically skilled Biomedical and Computer Science Engineer with 5+ years of experience in the design, development, and support of FDA-regulated medical devices and R&D systems. Proven ability in CAD, FEA, image analysis, embedded programming, and lab automation with deep knowledge of GMP, ISO, and FDA regulations. Strong troubleshooting, process improvement, and project delivery capabilities in both hardware and software contexts.
Overview
8
8
years of professional experience
Work History
Biomedical Engineer
Texas Health Resources HEB
05.2021 - Current
- - Install, configure, troubleshoot, and validate Class I-III medical devices in compliance with FDA, GMP, and ISO standards.
- - Independently resolve hardware/software malfunctions using technical manuals, schematics, and diagnostic tools.
- - Manage incident reporting and corrective actions; reduce device TAT via process optimization.
- - Collaborate across hospital departments to ensure accurate preventative maintenance scheduling and documentation.
Lab QC/QA Specialist
HealthTrackRx
07.2020 - 02.2021
- - Implemented Lean Six Sigma processes to increase lab throughput and improve data accuracy in LIMS/LIS systems.
- - Conducted data validation and workflow optimization across quality and regulatory frameworks including HIPAA, CLIA, and CAP.
Biomedical Engineering Intern (R&D)
UTARI
06.2019 - 06.2020
- - Designed and prototyped smart wearable medical devices (e.g., diabetic insole, wound-healing glove) using CAD and molding techniques.
- - Conducted verification/validation testing, technical writing (SOPs, DMR, DHR), and compliance documentation.
- - Focused on FDA medical device development life cycle in support of Class II/III systems.
Research Assistant
University of Texas at Arlington
08.2017 - 08.2019
- - Developed and tested NIH-funded bioelectronic prototypes (FlexμCEA) for blood pressure control using nerve stimulation.
- - Built custom DAQ systems, validated animal study protocols, and conducted pre-clinical device trials.
- - Investigated predicate Class I/II technologies aligned with TENS systems for cardiac care.
Education
B.S. - Computer Science
Southern New Hampshire University
01.2024
B.S. - Biomedical Engineering
University of Texas at Arlington
05.2019
Skills
- CAD/Simulation: SOLIDWORKS, ANSYS, COMSOL
- Programming: C, C, Java, Python, MATLAB, UML, SDLC, Agile/Scrum
- Image Processing: MATLAB, MITK
- 3D Printing: Filament & Resin (KISSlicer)
- Data Acquisition: LABVIEW
- Regulatory Compliance: GMP, FDA (Class I-III), ISO-9000, 21 CFR 820
Additional Information
Open to Relocation within DFW
References Available Upon Request
Timeline
Biomedical Engineer
Texas Health Resources HEB
05.2021 - Current
Lab QC/QA Specialist
HealthTrackRx
07.2020 - 02.2021
Biomedical Engineering Intern (R&D)
UTARI
06.2019 - 06.2020
Research Assistant
University of Texas at Arlington
08.2017 - 08.2019
B.S. - Computer Science
Southern New Hampshire University
B.S. - Biomedical Engineering
University of Texas at Arlington
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