IT consulting firm that provides AI/ML solutions, application development, website management, and cloud services for small business owners.

• Leading AI/ML initiatives to improve complaint management system efficiency within the product surveillance department for a major healthcare company.• Specializing in NLP for unstructured data to perform Sequence Classification, Summarization, Named Entity Recognition, and Translation. Implementing best-in-class pretrained models, finetuned with in-house data, to function per task• Developing and training models for classification (binary and multi-class) and prediction; including, but not limited to: Feature Selection, Hyperparameter Optimization, Cross-Validation, and Ensembling/Stacking.• Performing production Model Selection and lifecycle Model Maintenance with Out-of-Sample retraining.• Implementing decision support tools for Regulatory Medical Device Reporting, Adverse Event Classification, Complaint Problem Coding, and the prediction of potential Business Escalations.

• Conducted EDA to formulate preliminary hypotheses, recognize patterns, engineer additional features, summarize main characteristics, and create informative visualizations.• Organized information and dataflows for KPI dashboarding. Prepared and delivered presentations to top management for the effective communication of project plans, statuses, risks/solutions, and achievements.• Generated automated systems to execute data wrangling, cleansing, and preparation across multiple data streams to pre-process and control data sets for pipeline ingestion or ad-hoc analysis.• Condensed broad business aims into targeted study objectives with specific data requirements and performance metrics goals.

• Technical Lead for Geographic Expansion projects in the Renal Department for Peritoneal Dialysis products.• Prepared and submitted documentation for FDA Regulatory Approvals (sNDA).• Performed process and product verification and validation.• Led Technical Design Reviews (TDRs) in order to communicate achievement of product and/or process development milestones to upper management and non-technical business audiences.

• Demonstrated adherence to and enforcement of recognized standards, regulations, legislation, and quality procedures as the Quality representative on cross-functional R&D teams.• Collaborated with design engineers during new product development to assign root cause for failed acceptance criteria and down-select product designs for development stage-gates. • Developed and approved DHF documentation, including, but not limited to: Product Requirement Specifications, Verification/Validation Studies, Test Method Validations, and Failure Mode Effect Analyses.• Became an ASQ Certified Quality Engineer.

• Directed the activities of multiple change control projects for the fluid systems disposable medical products portfolio to ensure prompt execution and closure.• Utilized DMAIC tools to assign root cause for product and/or process failures to achieve data-driven solutions.• Executed Supplier Notice of Change (SNC) activities that were required to ensure the continuity of our raw material supply chain and partnered with personnel at affected manufacturing plants to facilitate timely conversions.

• Developed and executed equipment validation protocols for new and modified equipment (DQ, IQ, OQ, PQ, & PPQ), authored software and lab equipment test cases, and executed Test Method Validations (TMVs).• Developed and performed calibration procedures with traceability to NIST standards to meet accuracy, precision, and Test Uncertainty Ratio (TUR) requirements.• Received Six Sigma Green Belt for validation of the PLC data table compare function that eliminated incorrect parameter recipe verifications on critical manufacturing equipment for medical supplies.

• Production Manager of 30+ employees on an insulated glass production line for vinyl window manufacturing.• Scheduled and directed manufacturing and maintenance activities to meet production demands and quality specifications.• Performed customer visits at construction sites to troubleshoot and resolve product issues.

• Industrial engineering intern at construction material distribution center.• Performed time studies on shipment loading/unloading activities to uncover areas for execution improvement.• Authored report of recommendations for material storage, resource allocation, ergonomic techniques, and material handling best practices to optimize shipment loading/unloading activities.