Systems Engineer

Systems Engineer ROCGJP00039188

• 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, 18 Month Assignment

A leading biotechnology company is seeking a Systems Engineer. T he successful candidate will drive product definition, including requirements, system architecture design, risk analysis, and solution implementation to meet IVD standards.

Sy stems Engineer Responsibilities:

• System Lifecycle Management: Apply Systems Engineering to product definition, requirements, risk analysis, and testing.
• Project Execution: Manage requirements, risk analysis, and verification/validation.
• Industry and Technology Analysis: Research trends, emerging technologies, and competitive products' differentiation.
• Cross-functional Collaboration: Work with R&D, Marketing, Operations, Quality, and Regulatory teams to ensure alignment.

Systems Engineer Qualifications:

• 4 years of experience (or Master's with 2 years, or PhD).
• Bachelor's degree in Engineering, Biomedical Sciences.
• Experience with electro-mechanical devices.
• Experience in front-end Systems Engineering design & development deliverables around requirements, risks & architecture.
• Ability to work independently and cross-functionally with many different groups to solicit needs and complete trade-off analyses.
• Demonstrated knowledge in systems and hardware integration and testing, including requirements engineering, tradeoff analysis, risk management, and verification/validation using tools like RETINA
• Experience in a regulated environment, familiar with FDA, ISO, and other relevant diagnostic product standards.
• Interest in innovative technologies and understanding of the IVD competitive landscape.
• Deep knowledge in reliability, manufacturability, and usability is preferred.
• Excellent organizational skills, capable of evaluating, prioritizing, and managing multiple projects efficiently is preferred.

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