embecta · 6 days ago

Staff Firmware Test Engineer

Andover, MA

Full-time

Onsite

Mid, Senior Level

8+ years exp

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Responsibilities

Design and integrate automated test frameworks, tools, and processes to improve testing efficiency and effectiveness

Develops and optimizes physical test methods and test fixtures to support the design verification, validation, and commercialization of new medical device products.

Performs hands-on and simulated testing for design verification and test method development.

Drafts engineering technical reports, test method work instructions or procedures and test method validation related documents.

Plans, leads/executes test method validation (TMV) in preparation for design verification testing for regulatory submissions.

Authors and executes design verification test protocols in support of regulatory submissions of Class II (or Class III) medical devices.

Conducts functional and performance testing of products to ensure that the product and its components meet the required specifications.

Applies sound engineering principles and practices to the design and testing of medical devices.

Executes routine and non-routine mechanical and analytical testing to support the development, verification, and validation of new products.

Participate in cross-functional product design to ensure testability and work collaboratively with the R&D team on all levels of testing, ranging from unit to verification testing

Support the R&D team in data review, analysis, and interpretation. Identifies and reports out of specification results, data, and atypical/unexpected events that occur during testing activities and supports associated investigations, impact assessments and Root Cause Analysis (RCA)

Qualification

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Test experienceWriting protocolsExecuting protocolsPhysical device testingTest implementationPythonOther languagesProblem-solvingHard-workingInterpersonal skillsTeamworkAutomation FrameworksEmbedded DevicesPipeline AutomationSource Code RepositoriesAzure DevOpsRobot Test AutomationC ProgrammingUnit TestingAutomated TestingLab ToolsOscilloscopesLogic AnalyzersMedical Device Testing