Systems Engineer - Software

This is an onsite position that pays - / hr, depending on 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

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 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 years of experience (or Master’s with 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.

EEO :