What are the responsibilities and job description for the Software Tool Verification and Validation Engineer position at Noblesoft Technologies?
Job Title: Software Tool Verification and Validation Engineer Location: Newton, MAJob Summary We are seeking a detail-oriented Software Tool Verification and Validation Engineer to ensure the reliability, accuracy, and compliance of software tools used in development and production environments. This role involves planning, executing, and documenting validation activities in accordance with industry standards and regulatory requirementsKey Responsibilities Develop and execute verification and validation plans, protocols, and test cases for software and hardware tools.Collaborate with cross-functional teams to define validation requirements.Perform risk assessments and impact analyses for software changes.Document verification and validation results and maintain traceability matrices.Ensure compliance with relevant standards (e.g., FDA 21 CFR Part 11, ISO 13485, GAMP 5).Support audits and inspections by providing validation documentation. Test Planning and DesignDevelop comprehensive test plans, test cases, and test scripts based on software requirements and design specifications.Ensure test plans cover all functional and non-functional requirements, including performance, reliability, and security.Test ExecutionExecute manual and automated tests to identify software application defects.Conduct regression testing to ensure existing functionalities remain unaffected by new changes.Perform exploratory testing to uncover potential issues not identified by formal test cases.Documentation and ReportingDocument test results, including detailed descriptions of defects and steps to reproduce them.CollaborationWork closely with software developers, and systems engineers, to understand software requirements and functionality.Compliance and StandardsEnsure testing activities comply with relevant regulatory standards (e.g., FDA, ISO 13485, IEC 62304).QualificationsEducation Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field.ExperienceMinimum of 7 years of experience in software testing, preferably in the medical device industry.Experience with testing tools and frameworks (e.g., ClearQuest, Jama).Familiarity with regulatory standards and guidelines for medical devices (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 62304)
Salary : $35