Software Tool Verification and Validation Engineer

Newton, MA - USA

Monthly Salary: Not Disclosed

Posted on: 4 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Title: Software Tool Verification and Validation Engineer
Location: Newton MA

Job 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 requirements

Key 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 Design
Develop 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 Execution

Execute 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 Reporting

Document test results including detailed descriptions of defects and steps to reproduce them.

Collaboration

Work closely with software developers and systems engineers to understand software requirements and functionality.
Compliance and Standards
Ensure testing activities comply with relevant regulatory standards (e.g. FDA ISO 13485 IEC 62304).

Qualifications
Education
Bachelors degree in Computer Science Software Engineering Biomedical Engineering or a related field.
Experience

Minimum 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)

Job Title: Software Tool Verification and Validation Engineer Location: Newton MA Job 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...

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 Design
Develop 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 Execution

Execute 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 Reporting

Document test results including detailed descriptions of defects and steps to reproduce them.

Collaboration

Work closely with software developers and systems engineers to understand software requirements and functionality.
Compliance and Standards
Ensure testing activities comply with relevant regulatory standards (e.g. FDA ISO 13485 IEC 62304).

Qualifications
Education
Bachelors degree in Computer Science Software Engineering Biomedical Engineering or a related field.
Experience

Minimum 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)