Systems Engineer: Assay Development for Diagnostics

Roche

Tucson (AZ)

On-site

USD 73,000 - 135,000

Full time

2 days ago

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Job summary

Roche Tissue Diagnostics seeks a Systems Engineer - Assay Development to support our R&D efforts in Tucscon, AZ on site. You will define requirements, manage risks, and drive verification and validation activities across complex diagnostic projects.

Collaborating with R&D, Quality, and Regulatory teams, you will ensure traceability, align with FDA/ISO standards, and craft robust validation plans while presenting clear solution options for stakeholders.

Qualifications

Educational Background: Bachelor's degree in Engineering, Biomedical Sciences, or related technical field with 4 years of experience (or a Master’s degree with 2 years of experience, or a PhD).
Experience in assay development at a medical device company.
Regulatory Familiarity: Experience with FDA, ISO, and other regulatory standards for diagnostics products, especially regarding requirements, risk, and validation.
Strategic Mindset: Interest in innovative technologies and understanding of the competitive IVD landscape.

Responsibilities

System Lifecycle Management: Focus on requirements engineering, risk management, and verification & validation stages of the lifecycle.
Industry and Technology Analysis: Research trends and technologies to identify opportunities for robust requirements and validation strategies.
Cross-functional Collaboration: Work with R&D, Marketing, Operations, Quality, and Regulatory for traceability and validation alignment.
Customer-Focused Innovation: Engage with stakeholders to define validation criteria and address customer needs.