Stephen Mathew
Rowlett
Summary
Biomedical Engineer with a robust background in risk management and data validation, leveraging engineering principles to enhance human health outcomes. Skilled in data analysis, regulatory compliance, and strategic planning, with expertise in tools such as MATLAB, Python, and Solidworks. Demonstrates strong problem-solving abilities and adaptability, consistently delivering reliable and impactful results in dynamic environments, with a focus on innovative solutions to improve quality of life for individuals with medical conditions. Developed key skills in quality engineering and process improvement within manufacturing environment. Adept at identifying inefficiencies and implementing effective solutions. Seeking to transition into new field, leveraging analytical and problem-solving abilities for impactful results.
Overview
4
4
years of professional experience
Work History
Quality Engineer
Uniwell Labs
Fort Worth, TX
04.2025 - Current
- Supported quality risk management and regulatory compliance activities for products and processes, including FSMA 21 CFR 117, ISO 14971, HACCP/HARPC, and pFMEA, assisting with risk assessments, documentation, and reviews.
- Executed day-to-day quality engineering tasks such as internal audits, environmental monitoring support, metrology calibration record review, batch record review, and specification compliance for raw materials and finished products.
- Lead validation and documentation efforts by conducting IQ/OQ/PQ, process and cleaning validations, SOP development, change control reviews, labeling compliance, and regulatory documentation updates.
- Contributed to continuous improvement and cross-functional quality support through CAPA investigations, complaint/root cause analysis, quality metrics tracking, supplier quality support, and coordination with manufacturing and lab teams.
Quality Engineer
Abbott
Plano, TX
09.2024 - 12.2024
- Consolidate legacy documents, enhancing quality plans with strategic updates.
- Reviewed 1000+ risk files, improving data accuracy and compliance.
- Streamlined document management, reducing redundancy and boosting efficiency.
- Collaborated on quality plan updates, driving process improvements.
- Conducted data analysis, refining risk management strategies.
VALIDATION ENGINEER
PSC Biotech
Dallas, TX
05.2022 - 09.2023
- As a Computer Systems Validation Engineer/Data Migration Specialist at PSC Biotech Corporation, I mastered Katalon/Selenium for QMS software testing and ensured accurate data migration for BioMarin's operations
- Supported validation engineers with software testing tools.
- Resolved complex migration issues for seamless transitions.
- Contributed to successful project outcomes through data validation efforts.
Education
BACHELOR OF SCIENCE - BIOMEDICAL ENGINEERING
The University of Texas at Dallas
Richardson, TX12.2021
Skills
MATLAB, C, LABVIEW, Solidworks, Simulink, Multisim, Arduino, Microsoft Office, XG-X Keyence Software, Laser Linc Total Vu, Breadboard, Oscilloscopes, Function Generator, Multimeter, Soldering, CNC Controllers, Encoders, Katalon, Python, Java, Risk management, Risk mitigation, Data analysis, Regulatory compliance, Strategic planning, Control plan development, Quality processes, Non-conforming material reports, Root-cause analysis, Quality assurance, Quality risk assessment, Team leadership, Quality documentation
Timeline
Quality Engineer
Uniwell Labs
04.2025 - Current
Quality Engineer
Abbott
09.2024 - 12.2024
VALIDATION ENGINEER
PSC Biotech
05.2022 - 09.2023
BACHELOR OF SCIENCE - BIOMEDICAL ENGINEERING
The University of Texas at Dallas