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).

Overview: This is an onsite position for a motivated, hands-on Senior Systems Engineer who has experience with electro-mechanical devices.

Must Have: Systems Engineering, Electro-Mechanical Devices, Test Method Validation (TMV), Design of Experiments (DoE), Sensor Data Analysis/Python, Verification & Validation (V&V), * 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