Systems Engineer - Software

Overview

Title: Systems Engineer - Software

Description: This is an onsite position. 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)

Roche 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.

• 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 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.