Description

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

This role is on-site.

Responsibilities

• Develop comprehensive test plans, test cases, and scripts based on software requirements and design specifications.
• Execute functional and non-functional tests, including performance, reliability, and security validation.
• Document test results, defect descriptions, and reproduction steps to maintain regulatory compliance.
• Maintain defect logs and generate test reports for management and regulatory review.
• 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 C# for test automation.
• Experience with SQL.
• Familiarity with medical device regulatory standards: FDA 21 CFR Part 820, ISO 13485, and IEC 62304.
• Experience using testing tools and frameworks such as ClearQuest or Jama.
• Strong understanding of software development and testing methodologies.
• Bachelor's degree in Computer Science.

Key Skills

Education

Bachelor's degree in Computer Science