Job Title: Systems Engineer (SW Requirements and Risk)
Duration: 10 months
Location: Tucson, AZ 85755

Description:
**Experience writing SW requirements and completing risk analysis
**Ability to work independently and cross-functionally with many different groups to solicit needs and complete trade off analyses
**Experience in a regulated medical device industry

Tissue Diagnostics is seeking a Systems Engineer to drive software product definition, including requirements, system architecture design, risk analysis, and solution implementation to meet IVD standards. This role focuses on advancing cancer diagnostics through state-of-the-art testing automation, providing over 250 cancer tests and associated instruments globally.

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.
• Cross-functional Collaboration: Work with R&D, Marketing, Operations, Quality, and Regulatory teams to ensure alignment.
• Customer-Focused Innovation: Engage with business leaders and VoC representatives to align technical solutions with customer needs.
• Technical Problem Solving: Analyze complex technical challenges, present solutions, and facilitate informed decision-making.

Educational Background:

• Bachelor's degree in Engineering, Biomedical Sciences, or related technical field with 4 years of experience (or Master’s with 2 years, or PhD).

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.

Preferred:

• Specialized Skills: Deep knowledge in software reliability, manufacturability, and usability.
• Leadership and Communication: Proven ability to build authority and accountability within a team, with strong collaboration and communication skills.
• Organizational Skills: Excellent organizational skills, capable of evaluating, prioritizing, and managing multiple projects efficiently.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 42.00/hr.