Systems Engineer - Software

Systems Engineer – Software

• 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.

• 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.

• 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.