MEDICAL DEVICES

 

  • Foundation Medicine-SaMD Cancer Biomarker medical device AI software used by Oncologists
    • Compliance-review and approval of SaMD software verification documents per IEC62304  
    • Review of SaMD validation documentation
    • Generated a SDLC Gap Assessment per IEC62304
    • Wrote a Lean Agile SDLC to decrease cycle time, increase quality, and meet IEC62304 and ISO14971
  • Bayer Radiology
    • Validated $10M SAL10 barrel linear and plunger linear computerized production equipment

  • Johnson and Johnson Cordis-Medical device validation-coronary stents and catheters
    • ​Performed 21 CFR Part 11 Validation for ERP JD Edwards system
    • Part of a team responsible for creation of J&J Cordis Validation methodology
    • Performed Software Quality Compliance of JD Edwards system per SDLC based on GAMP
    • Performed Vendor Site Audits, wrote the final reports for functional area senior manager   

  • Medtronics Heartware-Ventricular Assist Heart pump with embedded software
    • Due to an FDA warning Letter, performed gap assesments of validated systems   
    • Performed remediation validations for 85+ systems to align with revamped validation framework 

  • SIEMENS-Diagnostics
    • Validated Production spreadsheets

 

  • Diasorin-Diagnostics
    • Performed validations for Lab Equipment and IT COTS and COTS Configured software
  • Zimmer- Implants
    • ​Deployment Manager for CAPA Trackwise Module
  • Orthosensor-Verasense
    • ​Product Maintenance QA Engineeer-Wrote, reviewed, and approved software and implant documentation 
  • Abbott-Auto Assist glucose meter
    • ​Performed validation of ADC Advanced Auto Assist Apollo glucose meter clinical software

  • ​QA and Regulatory Director at DermaSensor-
    • Standalone medical device software Verification under IEC62304,TIR45, Software Guidance.Wrote Agile SDLC 
    • Validation of embedded software, CRM, IT systems 
    • Hardware Product Development, Design Controls, Verification and Validation,DHF, Design Transfer, DMR
    • Non-clinical tests coordination with labs. 
    • Usability/Human Factors study 
    • Labeling 
    • Prepared Modular PMA, DeNovo dossier. IDE, Breakthrough device 
    • MDR gap assessment, Technical File preparation for CE marking and product certification with TUV-SUD
    • Fielded product in New Zealand and Australia  

  • QA and Regulatory Director at MedTek   
    • ​SaMD, SiMD-Embedded Software verification under IEC62304, TIR45, Software Guidance. Wrote Agile SDLC
    • Validation of SaMD, Embedded Software 
    • Hardware Product Development, Design Controls, Verification and Validation,DHF, Design Transfer, DMR
    • Supplier Qualification
    • QMS Implementation under ISO13485, ISO14971, 21 CFR Part 820,11,CAPA,MDR,Complaints 
    • 510K  

 

 PHARMACEUTICALS

  • QA Manager at ANDRX Corporation-Distribution and IT systems QA.  Validated ERP non-product software, IT Software 
  • Luitpold -Validated Lab equipment, Electron microscope, and COTS and COTS Configured applications 
  • Noven-Validated $5M Seineader and Pester Serialization equipment  

 

OTHER WORK

 

Software Quality Assurance Director-QPay 

  • Implementation of Software QA framework: SRS,Testing,RTM, Automation for Cellular Carrier Payment Platforms 

 

Department of Defense 

  • CECOM (Communications and Electronics Command)
    • Sensors; electronic warfare and surveillance systems software development
  • MICOM (Missile Command, Software Engineering Directorate) missile software testing 
    • PATRIOT-Phased Array Radar Intercept on Target anti-ballistic missile testing at White Sands Missile Range
    • MLRS-Multiple Launch Rocket System testing  
    • TOW-Tube Optically Wire Guided Missile testing

Gables Engineering -Avionic Panels 

  • QA for BOEING and Airbus -TCAS (Traffic Collision and Avoidance), ILS (Instrument Landing), COMM, and others  ​​

Motorola Communication Systems and Infrastructure

  • CMM Process maturity implementation and certification