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
ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.
Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
Founded in 2000
2000+ Employees
The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.
Skills
Atlassian JIRAunmatched
Biomedical Softwareunmatched
Biotech and Pharmaceuticalunmatched
Bug Tracking/Defect Managementunmatched
Data Analysisunmatched
Design Verificationunmatched
Documentationunmatched
Electrical Engineeringunmatched
FDA (Food and Drug Administration)unmatched
Federal Aviation Administration (FAA)unmatched
Health Planunmatched
ISO (International Organization for Standardization)unmatched
Identify Issuesunmatched
International Electro-Technical Commission (IEC)unmatched
Interpret Regulationsunmatched
Medical Equipmentunmatched
Python Programming/Scripting Languageunmatched
Quality Assurance Methodologyunmatched
Regulationsunmatched
Requirements Managementunmatched
Systems Engineeringunmatched
Test Plan/Scheduleunmatched
Testingunmatched
Traceabilityunmatched
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