Daniel K. Email & Phone Number

Bloomington, In, Us

Bloomington, Indiana, Us

• Led Process and Test Method Validation (TMV) initiatives within a Tech File-focused team to achieve EUMDR compliance, meeting critical deadlines, and implementation benchmarks.• Cross-trained in Process Validation and Manufacturing Engineering to support versatile production requirements. • Conducted PFMEA, PVPnR, and Trace Matrix analyses to enhance product reliability and risk management.• Drafted and reviewed Hazard Analysis documents, collaborating with clinical and sustaining leads to ensure comprehensive risk assessment.• Developed and implemented Test Method Validation (TMV) protocols, Controlled Training materials, and detailed Test Method Instructions.• Implemented 21 CFR Part 11 requirements, ensuring regulatory compliance in electronic record management and that it met Good Documentation Practices.• Led Computer System Validation (CSV), including IQ, OQ, PQ protocol creation and execution.• Drafted CS, URS, and FRS documents, overseeing their successful implementation.• Created and analyzed Functional Risk Assessments to address potential product risks.• Composed and verified Traceability Matrices to maintain strict alignment between requirements and validation outcomes.• Authored a Validation Plan and completed comprehensive Validation Reports to facilitate project closeout for numerous devices for a new manufacturing floor.• Prepared Transfer Packages for smooth implementation and training at company sites.• Investigated CAPA field reports, analyzed device complaint histories, and researched complaint trends to enhance QC steps and reduce high-risk occurrences.• Analyzed Manufacturing Non-conformances to drive process improvements.

Richardson, Tx, Us

• Collaborated with clients, Dr. Leveno and Dr. Ochoa, from UT Southwestern Medical Center to create a novel medical device to monitor kidney function in real time for the hospital setting• Using Solid Works 2019, modeled and tested numerous design ideas to ensure optimal mechanical and fluid dynamics• Collaborated with an interdisciplinary team to meet client set parameters and design constraints with a defined budget• Software integration and physician interface using Arduino IDE and Google API to allow Wi-Fi capability and real time monitoring and displayed statistics via Google Sheets• Separate mobile app creation using MIT App Inventor to allow serial data monitoring and alert features while connected to the device via Bluetooth• Used MS Project for team management and deliverable development for the client • A provisional patent was submitted and approved under the name “Nephrometer”

Richardson, Texas, Us

• Worked with doctors and surgeons to research and conduct Vagus Nerve stimulations for behavioral and auditory responses to help improve and diagnose various mental illness with a particular interest in Alzheimer’s• Used MATLAB to conduct and analyze stimulations with cortex mapping for visual analytics• Trained in animal surgery, animal care, and drug solution creation• Nerve circuitry and wiring soldered and created by hand for animal surgery

Middleton, Wi, Us

• Assembled layout and product displays for Lowe’s and Home Depot• Analyzed sale records to ensure units were replenished and properly represented at all times• Responsible for store inventories in the Fort Worth district

Middleton, Wi, Us

• Assembled layout and product displays for Lowe’s and Home Depot• Analyzed sale records to ensure units were replenished and properly represented at all times• Responsible for store inventories in the Fort Worth district

Austin, Texas, Us

Item delivery and customer support

Menomonee Falls, Wisconsin, Us

Cross Trained in all clothing departments. Freight loader for stock replacement and management. Cashier and customer service department.

Bachelor Of Science - Bs, Biomedical/Medical Engineering

Biomedical/Medical Engineering