Manual Medical Device Test Engineer II

Responsibilities

• Test the functionality and performance of the systems software
• Develop and execute manual test plans and scripts designed to detect problems
• Maintain broad understanding of current testing software technologies
• Ensure systems software meets technical and functional requirements
• Perform workflow analysis, document test results and recommend quality improvements
• Work with engineers to resolve software defects and diagnose/improve product configuration for current and future models

• Bachelor's degree and a minimum of 2 years of relevant experience OR Master’s degree with a minimum of 0 years of relevant experience
• Knowledge of Medical Product verification, IEC- 62304 and FDA guidance in a technical discipline, preferably software related (Software Engineering, Computer Science, Computer Engineering or related technical field) with a minimum of 2 years of software verification experience
• Strong understanding of creating test protocols for verifying software requirements
• Ability to work with QA to ensure testing meets Quality and Regulatory needs
• Strong understanding of good documentation practices
• Experience using a tool or repository for managing test cases (Polarion, TFS, Test Rail, JAMA etc)
• Ability to manage, track and upgrade multiple hardware and software configurations.

• manual testing
• test plans
• test scripts
• workflow analysis
• software verification
• test protocols
• documentation practices
• quality improvements
• software configuration management

• problem-solving
• collaboration
• communication
• analytical thinking