Responsible for the execution of Medical Device Software Testing and Test Cases.
Define, document and control of functional requirements; evaluate the design's overall effectiveness, reliability and safety
Write software and system functional, integration, and cybersecurity tests to ensure medical device requirements are adequately fulfilled.
Execute software test runs and documents the results for development phase and formal testing.
Maintains software traceability information for testing.
Participate in design, development, risk assessment, and other software and device development processes and test case reviews, as needed.
Install, configure and test operating systems, application software, and system management tools
Plan and develop integration test architecture for verification and validation. Apply various tools for writing test cases and tracking results, such as Helix
Support the development team with exploratory testing or assistance in identifying anomalies or specific conditions for anomalies
Participate in regression analysis and determination of testing scope.
Maintain records for test equipment.
Write CSA test protocols and perform testing for software tools.
Track status of equipment used for software test and ensures controlled state, calibration, and documentation for that equipment.
Organize and direct activities of junior test engineers and/or external test groups, or assists with those activities.
Meet all documentation and test practice expectations for regulated

medical device

Apply engineering knowledge to the design and development of new software products as well as product changes and enhancements.

Telecommuting permitted. Can work remotely from anywhere in the U.S. reporting to company headquarters. Salary $184,974/yr

Job Requirements:

Bachelor's degree or equivalent in Software Engineering, Electrical Engineering, Electronics Engineering, or related field, plus 60 months (5 years) of post-bachelor's work experience in the job offered or in a related occupation in Software and Systems Testing in the medical device industry.

Must also possess:

4 years of experience in verification and validation of medical devices, including manual and automated testing;
4 years of experience in reviewing requirements for testability, completeness, and adequacy for medical devices.
2 years of experience in regression analysis and analysis of impact of updates and anomaly fixes.
2 years of experience in preparation of test reports and documentation as part of 510k regulatory submissions.
Any and all experience may be gained concurrently.
Telecommuting permitted.

To apply, please email your resume with reference # ENC101 to Cory.Millar@redbock.com or apply at https://www.linkedin.com/company/redbock/jobs/

EOE.