Job Description

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

• Experience in front-end Systems Engineering , including requirements engineering, architecture definition, risk management, and trade-off analysis
• Hands-on experience with systems and hardware integration and testing
• Experience working in a regulated medical device environment
• Familiarity with FDA, ISO, and other applicable diagnostic product standards
• Experience using systems engineering tools such as RETINA or similar platforms

Preferred Qualifications

• Deep knowledge of reliability, manufacturability, and usability engineering
• Strong leadership presence with the ability to build authority and accountability within cross-functional teams
• Excellent communication, collaboration, and stakeholder-management skills
• Strong organizational skills with the ability to prioritize and manage multiple workstreams effectively

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