Description

You 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 testing covering functional and non-functional requirements, including performance, reliability, and security.
• Document test results, defect logs, and steps to reproduce issues for regulatory compliance.
• Collaborate with software developers and systems engineers to validate software functionality.
• Maintain testing activities in alignment with FDA, ISO 13485, and IEC 62304 standards.

Required Skills

• 5+ years of experience in software testing, preferably within the medical device industry.
• Proficiency in Python or Java for test automation.
• Experience with ClearQuest and Jama.
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, and IEC 62304.
• Strong understanding of software development and testing methodologies.
• Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field.

Key Skills

Education

Bachelor's degree