Excellent opportunity for electronic Test Engineer to support the V & V testing of hardware and firmware for new medical device systems. This engineer will successfully plan, execute and document the verification and validation testing of complex electro-mechanical systems from the component level up to the integrated system level. This position includes writing test software, designing test circuits and mechanical test fixtures. The ability to understand the equipment under test and its requirements is essential. The engineer will be a self starter with a hands-on approach to testing, diagnosis and fault isolation. This position will work closely with R&D engineers in a multidisciplinary medical device development team (systems and controls, electrical, software and mechanical). Responsibilities include documentation of plans, procedures, test readiness reviews, work instructions and test reports, as well as improving the verification and validation process itself.
Primary responsibilities include:
Requirements include BS degree (EE, CS, Biomedical) and minimum 2 to 5+ years experience in electronic hardware development and test, and embedded software development and test. This includes experience with embedded system testing (motors, pumps, sensors, scales, etc), and experience with electrical lab equipment (Multi-meter, Scope, etc). Requires understanding of all phases of system development lifecycle (requirements, design, debug, test, defect resolution, and experience with Verification and Validation Test Process definition. Requires experience in programming languages C/C++, C#/.NET. and ability to design automated test applications as needed. Strong communication skills are required, including the ability to write V&V specifications and documentation, create plans and procedures, and present in one-on-one and group settings. Prefer experience working with safety critical design and test requirements (FDA, FAA, automotive), medical devices and associated international standards, and experience with commercial RTOS development and test. Prefer experience with data acquisition, emulation, simulation and modeling tools (e.g. LabVIEW, LabWindows, Matlab), and experience with Subversion (or similar configuration management tools/methods), and Requirements Management tools (e.g. DOORS).
- Perform verification and validation testing of components for a complex medical device system, including; controls and PCB testing, functional testing, system validation testing, test plan, procedure, readiness and results reviews, test traceability and documentation.
- This includes providing direction to technicians where the scope of the validation effort requires additional support.
- Participate in V&V development process improvement and test automation. Constantly strive to make the development process better and more efficient
- Diagnose, isolate and investigate problem reports. Problem report investigations drive product improvements or bug fixes.
Monster - 2 years ago
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