Experience

Mainstay Medical

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Senior Quality Engineer

  • Mar 2023 - Present

  Hat wearing enthusiast Hat wearing enthusiast



Abbott

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Quality Engineer

  • Jan 2022 - Mar 2023

  Production support QE in endovascular devices group. Process co-owner/SME for a stent-system finished-goods line handling quality issues / NCMR containment/ escalation, and process improvement;
  Investigation & improvement of process issues by DMAIC process & quality tools;Ensure compliance and audit readiness, and implement improvements to line for compliance & efficiency;Build relationship and communication with line personnel to ensure escalation and resolution of potential quality/scrap/ergonomic/etc issues. Show less

• Quality Engineer

  • Mar 2019 - Dec 2021

  Remediated guidewire and catheter device portfolios for EU MDR filing. Developed approaches to new, more stringent, regulatory requirements for leveraging historical process validations, sample product batch records, and communicating detailed manufacturing information in tech files.Built expertise in process validation, risk management, and serve as product/process SME for technical documentation and Q&A with notified body. Multiple class III guidewire portfolios (some 30 years old!) successfully approved under MDR, and led a stent delivery system through completion of manufacturing Q&A.Experience with audit support and auditor-facing roles with FDA, EU notified body and internal Abbott audits.Abbott CAPA certified, minor experience in investigation and root cause analysis. Identified and worked to solve inconsistencies and gaps in acceptance activities, process monitoring, and risk mangement. Show less



Nalu Medical, Inc.

• United States
• Medical Equipment Manufacturing
• 100 - 200 Employee

• Test Engineer Intern

  • Oct 2017 - Mar 2019

  Assembly & testing of electrical medical devices; Design verification testing of new product introduction devices; Layout, assembly and qualification of automated test equipment for production PCBs; Continuous improvement of production processes; Drawings and specifications for new mechanical subassembly, supplier management and first-article inspections. Assembly & testing of electrical medical devices; Design verification testing of new product introduction devices; Layout, assembly and qualification of automated test equipment for production PCBs; Continuous improvement of production processes; Drawings and specifications for new mechanical subassembly, supplier management and first-article inspections.



Aztec Electric Racing

• United States
• Appliances, Electrical, and Electronics Manufacturing
• 1 - 100 Employee

• Electrical Controls System Lead

  • Oct 2016 - Aug 2018

  Developed electrical control systems and circuit boards for small-scale Formula style race car with Formula - Society of Automotive Engineers at San Diego State. Worked to build and transfer technical knowledge in: electronics design, system design from user needs through implementation, high-voltage interfaces, safety FMEA, and PCB design in Altium Developed electrical control systems and circuit boards for small-scale Formula style race car with Formula - Society of Automotive Engineers at San Diego State. Worked to build and transfer technical knowledge in: electronics design, system design from user needs through implementation, high-voltage interfaces, safety FMEA, and PCB design in Altium