Enterprise Software Test Engineer II

Test execution and document software using manual and/or automation methodologies.

Thoughtfully develop testing strategies and protocols with state-of-the-art software best practices.

Develop test strategies, review test designs, and validate test scripts, verification of software.

Provide support for NPTV (Non-product tool validation).

Navigate the complexities of industry and government regulations to include IEC62304, IEC82304 and FDA QSR (Quality System Regulation) requirements.

Develop, document, and test software to ensure that the software meets the needs of end-users and achieves business goals.

Provide assistance to development teams.

Commitment to achieving and exceeding project goals and timelines.

Thrives in working with other disciplines to develop system-minded implementations that consider safety, performance, communication, user interface and other aspects of a final Medical Device product.

Work in a cross-functional Agile team across global R&D teams to test software for new and existing medical device products.

Participate in reviews of requirements, design, implement and test to ensure quality standards are met.

Analyze unexpected, undesirable, or non-understood behavior in software and in interactions of software with hardware.

Document results of defect analysis.

Follow the IEC 62304 standard and project documents such as the software development plan and coding standards.

Participates in other quality assurance functions, including, but not limited to, static code analysis, risk/hazard analysis, and test automation development.

Should be an excellent team player with good communication skills.

Should meet key business KPI/project metrices.