Senior Embedded QA Engineer

Highbrow LLC is an innovative manufacturer of medical devices in the United States, and they are seeking a Senior Embedded QA Engineer. In this role, you will design and execute tests for device firmware and manufacturing process software, ensuring the quality of software from both patient and internal customer perspectives.

Responsibilities:

• Work with CEE and US (PST zone) teammates
• Work with documentation (from test design/test protocol to take part in preparation of the release documentation)
• Perform manual system-level, functional, and acceptance testing on embedded systems software (C) and supporting desktop software applications (C#/.NET)
• Perform software tool validation: write and execute protocols for both custom and off-the-shelf software tools
• Perform exploratory and ad-hoc testing to identify edge cases and unexpected system behavior not captured by formal test protocols
• Develop written verification test protocols, then subsequently document and report test results in a manner consistent with regulatory standards and internal procedures
• Review requirements and design documentation to ensure technical accuracy as well as testability; act as a quality advocate throughout the development process

Requirements:

• Organized, detail-oriented, and proactive Manual Quality Assurance (QA) Engineer
• Design and execute tests of device firmware and manufacturing process software in support of Class II monitoring devices
• Act as an advocate for the quality of software from the perspective of both patients and internal customers
• Work primarily with firmware written in C and with C#/.NET windows desktop applications
• Understanding of QA principles and processes
• Understanding of requirements traceability and its role in compliance and test coverage
• Proactive communicator with ability to work independently as well as collaboratively in cross-functional teams
• Clear, concise, and organized written communication skills to convey methods and observations
• Familiarity with defect tracking tools (ideally JIRA)
• Experience in test management systems (preferably Jama Connect) including writing test cases, entering results, and facilitating review and sign-off processes
• Experience with electronic test equipment (power supplies, DMMs, oscilloscopes, etc) and ability to troubleshoot electrical and firmware issues on circuits/hardware
• Work with CEE and US (PST zone) teammates
• Work with documentation (from test design/test protocol to take part in preparation of the release documentation)
• Perform manual system-level, functional, and acceptance testing on embedded systems software (C) and supporting desktop software applications (C#/.NET)
• Perform software tool validation: write and execute protocols for both custom and off-the-shelf software tools
• Perform exploratory and ad-hoc testing to identify edge cases and unexpected system behavior not captured by formal test protocols
• Develop written verification test protocols, then subsequently document and report test results in a manner consistent with regulatory standards and internal procedures
• Review requirements and design documentation to ensure technical accuracy as well as testability; act as a quality advocate throughout the development process
• Experience with the software QA process in the medical device industry (ISO 13485, ISO 62304) or other regulated environment (e.g., FAA, SEC, DoD, Title 21, CFR part 11), and related verification, validation, and documentation requirements
• C / C++ / C# / .Net
• TCP / IP
• Cybersecurity
• Networking