Systems Engineer - Integration

Job Title:
Systems Engineer Integration
Location: 1910 East Innovation Park Drive, Tucson, AZ 85755
Duration: 10-month contract (with potential extension or conversion)
Pay Rate: $42 $ 45/hour (W2)
Benefits: Weekly pay, Medical, Dental, Vision
Work Schedule: Monday Friday, 8:00 AM5:00 PM (Hybrid)

The Opportunity
We are seeking a Systems Engineer Integration to join our R&D organization. In this role, you will be responsible for driving requirements definition, risk management, and verification & validation (V&V) activities across system-level projects. You will take ownership of critical deliverables, support informed decision-making, and ensure solutions meet IVD regulatory standards.

Key Responsibilities

• Systems Lifecycle Execution
  Apply systems engineering best practices across requirements engineering, risk management, and verification & validation phases of the system lifecycle.
• Requirements & Risk Management
  Develop, analyze, and maintain system requirements, risk assessments, and traceability artifacts to ensure regulatory and business alignment.
• Verification & Validation
  Plan and execute V&V activities, ensuring robust test strategies and compliance with applicable standards.
• Cross-Functional Collaboration
  Partner with R&D, Quality, Regulatory, Marketing, and Operations teams to ensure alignment on requirements, risks, and validation expectations.
• Customer & Market Alignment
  Engage with Voice of Customer (VoC) stakeholders and business leaders to translate customer needs into clear, testable system requirements.
• Technical Problem Solving
  Analyze complex technical challenges, propose multiple solution paths, and support data-driven decision-making.
• Project Execution & Tool Usage
  Execute project deliverables related to requirements engineering, configuration management, defect tracking, risk analysis, and V&V using company-specific tools.

Qualifications
Required

• Bachelors degree in engineering, Biomedical Sciences, or related technical field with 4+ years of experience
  or Masters degree with 2+ years , or PhD
• Strong understanding of systems engineering principles, including:
  • Requirements engineering
  • Trade-off analysis
  • Risk management
  • Configuration management
  • Verification & validation
• Experience working in a regulated environment with familiarity in FDA, ISO, or similar regulatory standards for diagnostic or medical device products

Preferred

• Hands-on experience with risk analysis methodologies (e.g., FMEA)
• Exposure to usability engineering and V&V test strategy development
• Strong communication and facilitation skills, with the ability to lead discussions around requirements, risks, and validation plans
• Excellent organizational skills with the ability to manage multiple priorities and complex documentation sets
• Familiarity with assay development processes
• Experience using RETINA (Requirements & Test Integration Application) and Lucid Spark/Lucid Chart
• Broad technical understanding across software, electronics, electro-mechanical systems, IT, and basic chemistry

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