Provides Quality support for continuous enhanced circulation therapy devices (C.E.C.T.) including inspection of returned product to determine root cause of failure, tracking root cause trends over time and performing final inspections. Reviews certificates of calibration for appropriate tolerancing based on applicable standards. Executes Health Hazard Evaluations (HHEs) to evaluate potential health hazards for patients or users due to the use of nonconforming product in the field. Develops corrective and preventive action (CAPA) plans for company-wide audit findings.

Performs quality engineering and root cause analyses for timely complaints. Develops corrective and preventive action (CAPA) plans for complaints and company-wide audit findings. Works with suppliers, manufacturing, engineering and other functional areas to verify timely implementation of corrective actions taken for complaint and remedial action issues.

Manufacturing Transfers: Leads the transfer of manufacturing for existing products or processes between authorized manufacturing sites. Manages scoping sessions with suppliers to discuss manufacturing transfer requirements and deliverables. Utilizes project management skills and tools to maintain aggressive timelines. Responsible for documentation updates including Inspection Guide Sheets (IGSs), Dynamic Control Plans (DCPs) / Process Failure Mode Effects Analysis (PFMEAs), Manufacturing Routers, Operational Codes and product listings in Global Item Master. Reviews and re-executes operational tests to reflect requirements of new manufacturing location: First Article Inspection (FAIs), Measuring System Analyses (MSAs), Gage Repeatability and Reproducibility (R&R) and Sterility/Process Validations.Additive Customs: Led the introduction of a new cleaning process for custom made additively manufactured (AM) parts in the Patient Specific Solutions Cell involving a new ultrasonic tank used for intermediate cleaning. Responsible for the calibration on the ultrasonic tank; Equipment Qualifications (EQs) and Performance Qualification (PQ) to validate a new intermediate cleaning step for Additive Custom parts. Analyzed organic residual test results using statistical methods and submitted results. Composed new operational documentation including Standard Operating Procedures (SOPs) and DCPs.

Developed databases for pharmaceutical and medical applications.

Researched and developed process improvements of trabecular metal for use in orthopedic implants using Chemical Vapor Deposition (CVD) manufacturing. Characterized material performance in a laboratory setting using Instron compression testing and porosity calculations from Scanning Electron Microscope (SEM) imaging. Utilized Minitab programming to statistically analyze test results. Refurbished a CVD reactor involving quality suppliers, budgeting, purchasing equipment and designing parts using SolidWorks.

Responsible for the remediation of design history files (DHFs) for Anterior Cruciate Ligament (ACL) reconstruction internal fixation implants, including inputs, outputs and verification and validation (V&V) per FDA 21 CFR 820.30 design controls and quality standards.

Led the development of a commercial device to assist people with OA and TKR to perform daily activities in the kneeling position. Presented prototype; filed provisional patent. For design validation, offloading of the knee was tested while using the device. We found that our subjects experienced offloading of 82-86% while in the device.

Led the development of a marketable application for QAS-based Antimicrobial polymer. Presented antimicrobial efficacy data at end of project. Use of microbiology laboratory techniques.

Shadowed orthopedic spine surgeons in the operating room. Identified unmet clinical needs in the operating room.

Summer Fellows Grant Recipient. Research the synthesis and mechanical characterization of Hydroxyapatite, HAP and Fluoride Substituted Hydroxyapatite, FHAP, which after optimization is used as the main agent in bone regeneration and the promotion of new bone growth and osteoblast formation. Use of laboratory techniques including FTIR, XRD and 3-Point Testing.