Senior Systems Engineer

ICONMA; Tucson (AZ); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health benefits

Referral program

Growth opportunities

Job summary

Our Client in Tucson, AZ is seeking a Senior Systems Engineer to drive regulatory-aligned system requirements, test development, and data analysis for medical device or biotech projects.

You will translate regulations into verifiable requirements, develop test beds, and manage defect lifecycles with the development partner. FDA/FAA/regulatory experience is a strong plus.

Qualifications

• Translate standards and regulations into engineering requirements.
• Interpret and trace ISO, IEC, FDA, and EU regulations.
• Extract functional and performance requirements from regulatory text.
• Decompose high-level "shall" statements into hardware/software/system requirements.
• Establish bi-directional traceability linking regulations, requirements, design and tests.

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, summarization for our development partner).

Skills

Regulatory requirement extraction

Traceability management (RETINA/DOORS/

Education

Bachelor’s degree in engineering

Tools

RETINA

DOORS

Jira

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

Why Should You Apply?

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