System Engineer

We’re hiring a Systems Engineer – Software to support cutting‑edge cancer diagnostics at Roche Tissue Diagnostics
. This role focuses on software requirements, risk analysis, and system definition within a regulated medical device environment.

Job Title:
Systems Engineer - Software

Job Location:
Tucson, AZ 85755

Job Duration: 12 months with possible ext

Position Summary

We are 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.

Description / Core Experience

• 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

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 Voice of Customer (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 Master’s degree with 2 years of experience, or PhD
• Demonstrated knowledge in software integration and testing
• Experience with requirements engineering
  , trade‑off analysis
  , risk management
  , configuration management
  , and verification/validation

Regulatory Familiarity

• Experience in a regulated environment
• Familiarity with FDA
  , ISO
  , and other relevant diagnostic product standards

Strategic Mindset

• Interest in innovative technologies and understanding of the IVD competitive landscape

Preferred Qualifications Specialized Skills

• Deep knowledge in software reliability
  , manufacturability
  , and usability

Leadership and Communication

• Proven ability to build authority and accountability within a team
• Strong collaboration and communication skills

Organizational Skills

• Excellent organizational skills
• Ability to evaluate, prioritize, and manage multiple projects efficiently

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