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ICONMA, LLC

Senior Systems Engineer

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Job Description

Senior Systems Engineer#26-43709

$51.78-$76.23 per hour

Tucson, AZ

Onsite

Job Description

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