Job Description


Responsibilities:
  • Partner with development teams to ensure compliance with FDA, ISO , IEC , ISO , and cybersecurity standards.
  • Provide quality oversight for Design History Files (DHF), risk management, V&V, and design controls.
  • Lead software risk management (RMF), including risk evaluation, control, and mitigation.
  • Drive Secure Product Development Framework (SPDF) and software security best practices.
  • Support Agile software development teams, ensuring regulatory and quality compliance.
  • Own and resolve CAPAs related to design control and software quality processes.
    • Requirements:
  • + years in medical device software quality engineering.
  • Deep knowledge of CFR , ISO , IEC , IEC , AAMI TIR, ISO , IEC , and cybersecurity standards.
  • Strong experience in SaMD, SiMD, cloud-based software, AI/ML, and security risk management.
  • Hands-on experience with design control document...

    • Apply for this Position

    Ready to join Katalyst HealthCares & Life Sciences? Click the button below to submit your application.

    Submit Application