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

A Software Systems Engineer to lead the definition, development, and risk management of software for in-vitro diagnostic (IVD) instruments. This role focuses on ensuring reliable and compliant software systems that support advanced cancer diagnostic solutions. The Systems Engineer will drive software requirements, perform risk analysis, and collaborate across functions including R&D, Quality, Regulatory, and Operations.

Responsibilities

• 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] /sanya @dawarconsulting.com