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This position requires familiarity with using Systems Engineering tools and concepts to assist with product lifecycle management, including identification of stakeholder needs, writing requirements, risk identification and management, failure mode and effects analysis (FMEA), fault tree analysis (FTA), event tree analysis (ETA), hazards analysis (HA), verification and validation (V&V) activities, quality control and documentation, process definition and improvement, and reliability, availability, and maintainability (RAM) data analysis.
A step in the right direction would be experience with several programming languages, platforms, and applications used for database management, statistical and physical modeling, and simulation (CAFTA, Access, Excel, Word, TIFA, Minitab, JMP/SAS, LabView, XML, IBM Jazz)
Medical device background is preferred
This will be a direct hire opportunity
Identification of stakeholder needs, documenting and updating requirements, writing test scripts and performing verification and validation (V&V) activities, and identifying and managing risk in the design and production phases.
Introduce fault tree analysis (FTA) and event tree analysis (ETA) into the company’s risk management toolbox as effective tools for visualizing failure mode logic and root cause analysis of systems with complex interactions.
Develop and maintain design failure mode and effects analyses (DFMEAs) and hazards analyses (HAs) for the main device as well as its subsystems and perform risk assessments (RAs) on design changes and software builds prior to release.
Issue traceability reports linking hazards, user requirements, and device functional specifications as part of the verification and validation (V&V) process.
Perform advanced analysis of the reliability, availability, and maintainability (RAM) on a new device being engineered by a small group of specialists for future release.
Responsible for writing, issuing, and reviewing technical reports, calculations, process documents, and other engineering products.