Senior Systems Engineer

Deliver V-Model systems engineering outputs and participate in design reviews. Conduct development and testing to evaluate performance against design specifications and system interactions. Ensure assays operate efficiently and effectively using the latest technologies and systems. Execute project deliverables-including requirements, risk, configuration management, defect management, and verification and validation-within the company-specific tool., TMV, Test Method Development, DoE, data analysis (python coding capability) –Digital outputs of a sensor and analyze the data –Test bed development –Troubleshooting skills –Developing comprehensive testing plans. –Executing hands-on testing protocols. –Authoring detailed technical reports. –Managing the defect lifecycle (collection, documentation, and summarization for our development partner).

Has expertise in translating industry standards, government regulations, and high-level stakeholder mandates into clear, testable engineering requirements. Has experience and ability to read, interpret, and trace legal, safety, and industry regulations (e.g., ISO, IEC, FDA, EU standards) without losing intent. Has experience in extracting functional, performance, interface, and constraint requirements from dense regulatory text and ambiguous stakeholder inputs. Has experience breaking down high-level “shall” statements or compliance mandates into lower-level requirements for hardware, software, and system. Has experience establishing bi-directional traceability (e.g., using tools like RETINA, DOORS, or Jira) linking source regulations * system requirements * design specifications * verification tests, Degree: Bachelor’s degree in Engineering (Electrical, Chemical, Biomedical, or Software preferred) –Years of Experience: 8 yrs –Experience in a FDA or FAA regulated environment is a strong plus; Medical device industry is ideal