System Engineer

Job Title : Systems Engineer

Location : Oro Valley, AZ (Onsite)

Duration : 18-Month Contract

About the Role

Seeking a motivated, hands-on Systems Engineer to support a new Project , focused on advancing cancer diagnostics through state-of-the-art testing automation. This role plays a critical part in defining product requirements, system architectures, and risk management strategies for in-vitro diagnostic (IVD) solutions used globally across more than 250 cancer tests and associated instruments.

This is an onsite position ideal for an engineer with strong electro-mechanical systems experience and a background in regulated medical device development.

Key Responsibilities

• Apply Systems Engineering principles across the product lifecycle, including requirements definition, system architecture, risk analysis, and verification & validation
• Manage front-end systems engineering deliverables related to requirements, risks, trade studies, and testing
• Plan and execute requirements management, risk analysis, and V&V activities
• Analyze complex technical problems, develop solution options, and support data-driven decision-making
• Conduct industry and technology assessments, including emerging trends and competitive product analysis
• Collaborate cross-functionally with R&D, Marketing, Operations, Quality, and Regulatory teams
• Engage with business stakeholders and Voice-of-Customer (VoC) representatives to align technical solutions with customer needs

Required Qualifications

Preferred Qualifications

Verification #Validation #RETINA #Diagnostics #pharma #pharmaceutical #lifescience #medicaldevice #IBMDOORS OR #DOORSNext #JamaConnect #Polarion #WindchillRV&S #PTCIntegrity #HPALM #QualityCenter #INCOSE #requirementsengineering #requirementsgathering #requirementsmanagement