Description

Verify medical device software compliance through rigorous testing and documentation.

This role is on-site.

Responsibilities

• Develop comprehensive test plans, cases, and scripts based on software requirements.
• Execute functional, performance, reliability, and security testing.
• Document test results, defect logs, and reproduction steps for regulatory audits.
• Collaborate with developers and systems engineers to validate functionality.
• Ensure all activities comply with FDA, ISO 13485, and IEC 62304 standards.

Required Skills

• 5+ years of experience in software testing, preferably in medical devices.
• Proficiency in Python or C# for test automation.
• Experience with automation testing and Selenium.
• Knowledge of Java.
• Familiarity with ClearQuest and Jama.
• Understanding of FDA 21 CFR Part 820, ISO 13485, and IEC 62304.
• Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or related field.

Key Skills

Education

Bachelor's degree in Computer Science