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Software Quality Engineer

1 month ago

Irving, United States KYYBA Full time
Job DescriptionJob Description

Support Activities:

  • This Position will be providing software quality support for new medical device product development which includes activities and tasks related to the software development lifecycle (SDLC) and FDA design controls (ISO 13485).
  • Education: BS degree in engineering, technical field or equivalent. Preferably software related such as computer science.
  • Experience: Minimum 5 years medical device software development lifecycle (SDLC), FDA design controls, software quality engineering, software verification/validation including traceability to requirements and risk analysis, defect reporting, and software configuration management.

Top 5 skills/requirements :

  • 1. 5 years medical device software development lifecycle (SDLC); In Vitro Diagnostics (IVD) preferred.
  • ISO 13485 (Medical Device QMS) and ISO 14971 (Medical Device Risk Management)
  • FDA design controls (820.30) 4. Software verification/validation experience