Software Test Professional

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Key SOFTWARE TEST Responsibilities

Independently plans and performs software verification and validation activities as part of the overall software engineering process for medical device solutions.

Integrates verification activities with requirements, risk management, development, and other project workflows and disciplines.

The primary responsibilities of the senior software test engineer are to:

• Design, develop and execute software tests to verify the design implementation meets documented requirements

• Plan and implement configuration of physical setup of equipment

• Discover, create, investigate, and track software defect records in a defect tracking database; support root-cause analysis; assess the impact of proposed fixes on affected and related functionality; and verify defect closure

• Report passed and failed requirements to the test team lead, the project team, and the department manager

• Generate objective evidence that the requirements, as written, have been satisfied by design outputs

• Communicate task status and software quality to the test team lead and manager

• Interact and collaborate with other personnel across project teams and disciplines

• Manage own priorities effectively, analyze complex software and workflow interactions, and develop effective solutions by applying knowledge across disciplines and improving verification approaches

• Multitask effectively on and across projects, when required

• Communicate effectively one on one as well as in groups at both high and low concept levels

• Grow into a product(s) subject matter expert

Knowledge and Skills

Must have knowledge of how software verification and validation activities integrate within a regulated software development process.

The senior software test engineer required skills include:

• Performing black-box, performance, stability and load testing, as required by the project

• Designing and developing manual and automated software tests from software requirements and specification documentation

• Providing documented evidence of test execution

• Participating in risk management activities (project, technical, and hazard)

• Ability to comprehend software specification documents

• Ability to peer-review software requirements and specification documents

• Ability to create tests for complex software modules from software requirements and specification documents

• Ability to define, estimate and track progress of tasks, and communicate project status

• Ability to create Requirements Trace documentation

• Ability to perform pe...