Biomedical Engineering co-op in medical device design and risk management
Ethicon Endo-Surgery, Johnson & Johnson
Jun 2006 - Mar 2007 (10 months)
• Reviewed and analyzed technical manufacturing requirements, functional specifications, product design history, and end-user guides for safe and effective use of minimally-invasive surgical instruments
• Wrote, edited, and updated technical requirements, functional specifications, product design history, installation guides, training materials, and end-user guides for proper use of minimally-invasive surgical instruments
• Assisted in development of a risk management plan for quality control of a new medical device using failure mode and effects analysis, fault tree analysis, and list of material analysis through the Six Sigma process
• Ensured that device met risk management requirements per ISO 13485 and ISO 14971 standards
• Assisted in