Senior Embedded Engineer

Job Description:

• We are looking for an organized, detail-oriented, and proactive Manual Quality Assurance (QA) Engineer.
• You would design and execute tests of device firmware and manufacturing process software in support of our Class II monitoring devices.
• In this role, you will act as an advocate for the quality of our software, from the perspective of both our patients and our internal customers, working primarily with firmware written in C and with C#/.NET windows desktop applications.
• Embedded / Tooling
• 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.

• 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

• 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.