University of Denver

Mahidol University

Robotic Systems Engineer at Smith & Nephew

Denver, Colorado, United States

Smith & Nephew

Robotic Systems Engineer

- Remediation team lead for EUMDR driven activities of Stealth Station S8 Hardware Devices
- Led a project to assess and fill regulatory and design gaps for devices including equipment trackers, spinal probes, spinal dilators, and navigated drill systems.
- Analyzed legacy DHFs to ensure products contained correct and complete documentation: User Needs, Design Inputs, Validation and Verification Testing, Risk Documentation (DFMEA, UFMEA, PRA)
- Successfully completed Gap Analysis and Gap Closure of high-priority devices to ensure compliance to EUMDR by May 2020 deadlines to prevent potential sales impacts
- Created tools and supported procedure updates to systemize remediation activities

Medtronic

System Engineer

Remediation Engineering Consultant

- Executes process and product remediation activities for Cardiovascular Balloon Catheters
- Validates manufacturing processes abiding by a change-controlled Quality Management System
- Writes and executes qualification protocols and reports (Tooling Qualifications, Software Qualifications, Operational Qualifications, Performance Qualifications)
- Improved traceability and quality assurance of manufacturing processes by proposing outsourcing strategies, maintenance plans, and calibration activities
- Conducts product remediation efforts from a customer-feedback, risk-based approach, delivering Use Specifications, Clinical Effects Analyses, User Needs, Design Input Requirements, Design Verifications, Design Validations, DFMEAs, PFMEAs, and UFMEAs
- Coordinates all remediation efforts with a multifunctional and interdisciplinary team, ensuring implementation activities do not obstruct other aspects of business

Cook Medical

Validation Engineer

Developing and producing a foam roller that combines self-administered foam rolling therapy with clinically-backed therapeutics to further promote musculoskeletal repair.

Remedy Supplies

Cofounder and Lead Engineer

I was part of an 8 person startup team developing a low-cost electroencephalogram and integrated software. I had direct involvement with R&D, production, business development, documentation, and research opportunities.

- Obtained understanding of noninvasive electrophysiological monitoring systems
- Constructed in-office facilities to improve inventory management and WAVi kit construction
- Administered WAVi EEG scans to customers
- Evaluated research opportunities by analyzing comparable experimentation and published articles in the related field, and drafted IRBs for prospective experiments
- Developed a bar-coding system to track the product from part sourcing to system delivery
- Analyzed cloud-based inventory management systems applicable for company needs
- Completed materials testing for a failure-prone component

WAVi Co

Operations Intern

- Produced and updated 3D models and part drawings using SolidWorks software
- Designed and documented testing procedures for components including, but not limited to OR Cables, Implantable Pulse Generators, and Paddle Leads
- Implemented in-house 3D printing capabilities for rapid prototyping
- Produced and compiled FDA documentation including part specifications, test specifications, and design history files
- Designed, fabricated, and implemented three systems to improve testing, manufacturing, and verification:
o	IPG – Charging Pad interface
o	Lead Cable Identification device
o	Paddle Lead Bend device

Nevro

Mechanical Engineering Intern

- Ground-up understanding of engineering concepts implemented in ski lifts including mechanical design and safety-monitoring systems
- Worked on and operated detachable and fixed lifts
- Calculated pull load values and factors of safety for splicing procedures
- Performed non-destructive analysis (NDT) on lift elements including, but not limited to chair arms, gears, and engine components

Thomas Ryan Crosby