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IL

Senior Systems Engineer

ICONMA, LLC
  • 🇺🇸 United States
  • On-site
  • Senior
  • 10 hours ago
  • $51.78 – $76.23 / hour
  • Python
  • Jira

Not enough detail in this posting to match

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

Senior Systems Engineer · ICONMA, LLC

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