Software Systems Engineer

Our client, a world leader in life sciences and biotechnology, is looking for a “Software Systems Engineer” based out of Tucson, AZ.

Job Duration: Long Term Contract (Possibility Of Extension)

Pay Rate: $39 - $42/hr on W2

Company Benefits: Medical, Dental, Vision, Paid Sick leave, 401K

• Develop and manage software requirements and system architectures for IVD instruments.
  

• Conduct risk analysis, trade-off studies, and impact assessments to ensure regulatory compliance.
  

• Support system integration, verification, and validation activities for software products.
  

• Ensure alignment with FDA, ISO 13485, ISO 14971, and IEC 62304 regulatory standards.
  

• Collaborate with cross-functional teams (R&D, Quality, Marketing, Operations, and Regulatory) to translate business and user needs into technical specifications.
  

• Manage configuration control, defect tracking, and change management throughout the development lifecycle.
  

• Contribute to design reviews, root cause investigations, and continuous improvement efforts.
  

• Provide technical expertise on software reliability, usability, and manufacturability.
  

• Participate in technology and competitive analyses to inform product innovation.
  

Qualifications

• Bachelor’s degree in Engineering, Biomedical Sciences, Computer Science, or related technical field.
  

• 4+ years of experience in systems or software engineering (or Master’s + 2 years, PhD + 0–1 year).
  

• Proven experience in:
  

  • Writing and managing software/system requirements
    

  • Performing risk management and analysis
    

  • Working within a regulated medical device environment
    

  • Managing verification and validation (V&V) activities
    

• Strong knowledge of systems engineering principles, trade-off analysis, and configuration management.
  

• Familiarity with FDA, ISO, and IVD standards.
  

If interested, please send us your updated resume at

[email protected]/[email protected]