Work Experience

Gentuity LLC

Supported manufacturing during line-down issues through NCRs and CAPAs
Represented Process Development in a cross-functional team for a new product through DV
Investigated, corrected, and presented root cause found from Design Verification to leadership
Designed new fixtures and processes to correct issues found in the field and manufacturing
Created a manufacturing plan to support Design Verification, Process Validation, and Clinical Trials
Nominated for “Cultural Ambassador” to improve company culture and employee retention
Duplicated and qualified a manufacturing line in a new site to 2X daily production capabilities
Wrote, executed, and reported on IQ/OQ/PQs for new and existing manufacturing processes
Collaborated with Quality Assurance to write a PFMEA and master validation plan for new products
Developed and validated test methods to verify the effectiveness of new processes

Designed and assembled fixtures to hasten product mechanical testing
- Worked directly with drop testing to design fixture that would ensure consistent, repeatable drops
  - All products needed to consistently withstand drops from varying heights depending on technical requirement documents
- Worked with IR lenses to restrain in fixed position
Analyzed FAI/CPK data to understand assembly issues for products
- Looked into tolerance stack-ups to specifically identify the problem
Communicated directly with JDMs about specific issues
- Attended weekly night meetings and presented issues observed in parts
Maintained a Stratasys PolyJet 3D printer on a daily basis
- Fixed issues by troubleshooting with technicians and running tests

Designed assembly fixtures on SolidWorks to aid technicians
- Created drawings for individual parts using GD&T
- Communicated with technicians to improve the design
  - Worked with fixtures in the clean room of the office which handled the lasers
Worked directly with a machinist to create easily manufacturable designs for a CNC machine
- Learned about the benefits and limitations of this method of manufacturing
Processed change orders from preliminary state to release using Empower (PLM Software)

Edited and created drawings using GD&T to modify tolerances based on manufacturing concerns
Designed, 3D printed, and tested tools for the manufacturing technicians to use
- Communicated directly with technicians on what tools can be helpful for production
Strategically ran tests to ensure work instructions were fully accurate and could be
Checked part compatibility from different suppliers
- Researched alternative vendors when there were cost/new revision concerns