Role: Senior Systems Engineer
Location: Tucson, AZ
Duration: 6+ Months
Pay Rate: $60 to $70
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)
Summary:
- 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.
Preferred Qualifications:
- 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
Key Responsibilities:
- 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).
Education & Experience:
- 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
