Description

You will verify medical device software to ensure compliance with regulatory standards and internal quality requirements.

Responsibilities

• Develop comprehensive test plans, test cases, and scripts based on software requirements and design specifications.
• Execute manual, automated, and regression tests to identify and document software defects.
• Perform exploratory testing to uncover issues outside of formal test cases.
• Document test results, defect logs, and reports required for regulatory compliance.
• Collaborate with software developers and systems engineers to validate software functionality.

Required Skills

• 5+ years of experience in software testing, preferably within the medical device industry.
• Proficiency in Python or Java for test automation.
• Experience using ClearQuest or Jama.
• Knowledge of regulatory standards including FDA 21 CFR Part 820, ISO 13485, and IEC 62304.
• Strong understanding of software development and testing methodologies.
• Ability to document detailed steps to reproduce defects and maintain compliance documentation.
• Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field.

Key Skills

Education

Any Graduate