Systems Engineer – Software

Systems Engineer – Software & Risk

Pay - $42 - $45/ hr on w2

Location , Tucson, Arizona, United States- Onsite

Contract - 11 months with possible extension

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

The Position: Systems Engineer (SW Requirements and Risk)

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.

• Who You Are:
  Educational Background: Bachelor's degree in Engineering, Biomedical Sciences, or related technical field with 4 years of experience (or Masters 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.