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HCLTech · 2 months ago

Test Lead - Embedded Device Testing

Newton, MA

Full-time

Onsite

Senior Level

$44/hr - $47/hr

7+ years exp

HCLTech is seeking a Test Lead for Embedded Device Testing to develop and execute verification and validation plans for software and hardware tools. The role involves collaborating with cross-functional teams, performing risk assessments, and ensuring compliance with relevant standards for medical device software.

Information and Communications Technology (ICT)IT ManagementOutsourcingSoftwareTelecommunications

No H1B

U.S. Citizen Only

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

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

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

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

Generate and maintain test reports, defect logs, and other documentation required for regulatory compliance

Communicate test outcomes and defect status to development teams and management

Work closely with software developers, and systems engineers, to understand software requirements and functionality

Ensure testing activities comply with relevant regulatory standards (e.g., FDA, ISO 13485, IEC 62304)

Stay updated with industry best practices and evolving regulatory requirements for medical device software

Qualification

Medical device testingRegulatory complianceTest automationTesting toolsFrameworksScripting languagesAnalytical skillsProblem-solving skillsAttention to detail