Senior Systems Engineer

Has experience establishing bi-directional traceability (e.g., using tools like RETINA, DOORS, or Jira) linking source regulations → system requirements → design specifications → verification tests. Has experience in extracting functional, performance, interface, and constraint requirements from dense regulatory text and ambiguous stakeholder inputs.

Our Client, a Biotech company, is looking for a Senior Systems Engineer for their Tucson, AZ location.
 
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).

 
Requirements:

• 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
• 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

 
Why Should You Apply?

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities