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 analysisHands-on experience with systems and hardware integration and testingExperience working in a regulated medical device environmentFamiliarity with FDA, ISO, and other applicable diagnostic product standardsExperience using systems engineering tools such as RETINA or similar platformsPreferred Qualifications
Deep knowledge of reliability, manufacturability, and usability engineeringStrong leadership presence with the ability to build authority and accountability within cross-functional teamsExcellent communication, collaboration, and stakeholder-management skillsStrong organizational skills with the ability to prioritize and manage multiple workstreams effectively#Verification #Validation #RETINA #Diagnostics #pharma #pharmaceutical #lifescience #medicaldevice #IBMDOORS OR #DOORSNext #JamaConnect #Polarion #WindchillRV&S #PTCIntegrity #HPALM #QualityCenter #INCOSE #requirementsengineering #requirementsgathering #requirementsmanagement