Software Validation Engineer

Position: Software Validation Engineer

Location : Newtons MA

Job Description:

The Software QA Engineer supports the team by ensuring the quality, safety, and reliability of embedded and application software for advanced medical devices. The role focuses on testing, documentation, and compliance with medical device standards.

Key Responsibilities

• Develop and execute software test plans and test cases for embedded and applicationlevel systems.
• Perform manual testing, including regression and systemlevel validation.
• Identify, document, and track software defects; collaborate with engineering teams for resolution.
• Ensure testing practices comply with medical device standards (ISO 13485, IEC 62304, FDA guidelines).
• Support continuous improvement of QA processes, tools, and test automation.

Required Skills

• Experience in software QA for embedded systems or safetycritical devices.
• Familiarity with medical device regulations and software lifecycle standards.
• Strong analytical and defecttracking skills.

Qualifications

• Bachelor s or Master s degree in Computer Science, Electrical Engineering, or related field.

QA certifications (ISTQB) are a plus.