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Medical Device Software Assurance Specialist

2 weeks ago

India Wipro Full time

About the Job:

As a Medical Device Software Assurance Specialist, you will be responsible for ensuring the quality and safety of our medical device software products. This includes managing software quality for Class-1 and Class-2 medical devices, evaluating software engineering activities, and reviewing software lifecycle deliverables.

Your Key Responsibilities:

  • Manage software quality for Class-1 and Class-2 medical devices (SiMD and SaMD).
  • Evaluate software engineering activities (requirements, risk analysis, design, development, documentation, integration, verification, validation, release) to ensure safe, secure, and effective medical devices.
  • Review software lifecycle deliverables and provide timely feedback to stakeholders.

What We're Looking For:

  • 7-10 years of experience in software or quality engineering in medical device development.
  • 2+ years of experience in software quality management of Class 2 or Class 3 medical devices (SiMD or SaMD).
  • Ability to handle multiple tasks/projects and manage priorities.
  • Strong technical writing skills.