Medical Device Software Quality Engineer

6 days ago


Irving, Texas, United States KYYBA Full time
Job Overview

We are seeking a highly skilled Software Quality Assurance Engineer to join our team at Kyyba. As a key member of our organization, you will be responsible for providing software quality support for new medical device product development.

Main Responsibilities

Our ideal candidate will have a strong background in software quality engineering and experience with FDA design controls, software verification/validation, and risk analysis. Key responsibilities will include:

  • Providing software quality support for new medical device product development
  • Ensuring compliance with FDA design controls and software development lifecycle (SDLC) requirements
  • Developing and implementing software verification/validation plans and procedures
  • Conducting risk analysis and defect reporting
  • Managing software configuration management
Requirements

To be successful in this role, you will need:

  • A BS degree in engineering, technical field, or equivalent
  • At least 5 years of experience in medical device software development lifecycle (SDLC), FDA design controls, software quality engineering, and software verification/validation
  • Strong knowledge of ISO Medical Device QMS and ISO Medical Device Risk Management
  • Excellent communication and problem-solving skills
What We Offer

At Kyyba, we offer a dynamic and supportive work environment, competitive compensation, and opportunities for career growth and development. If you are a motivated and detail-oriented individual with a passion for software quality engineering, we encourage you to apply for this exciting opportunity.



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