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Systems Engineer - Software ROCGJP00039034 * Hourly pay: $40-$45/hr * Worksite: Leading biotechnology company (Tucson, AZ 85755 - Onsite) * W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL * 40 hours/week, 11 Month Assignment A leading biotechnology company is seeking a Systems Engineer - Software. The successful candidate will drive software product definition, including requirements, system architecture design, risk analysis, and solution implementation to meet IVD standards. Systems Engineer - Software Responsibilities: * System Lifecycle Management: Apply Systems Engineering to SW product definition, requirements, risk analysis, and testing. * Project Execution: Manage software requirements, risk analysis, configuration, defect management, and verification/validation. * Industry and Technology Analysis: Research trends, emerging technologies, and competitive products for software differentiation. * Customer-Focused Innovation: Engage with business leaders and VoC. Systems Engineer - Software Qualifications: * 4 years of experience (or Master's with 2 years, or PhD). * Bachelor's degree in Engineering, Biomedical Sciences, or related technical field. * Experience writing SW requirements and completing risk analysis. * Experience in a regulated medical device industry. * Ability to work independently and cross-functionally with many different groups to solicit needs and complete trade-off analyses. * Systems Engineering Expertise: Demonstrated knowledge in software integration and testing, including requirements engineering, tradeoff analysis, risk management, configuration management, and verification/validation. * Regulatory Familiarity: Experience in a regulated environment, familiar with FDA, ISO, and other relevant diagnostic product standards. * Strategic Mindset: Interest in innovative technologies and understanding of the IVD competitive landscape. * Specialized Skills: Deep knowledge in software reliability, manufacturability, and usability is preferred.