IVD Systems Engineer - R&D & Validation

Roche Holding AG; Tucson (AZ); On-site; USD 60,000 - 112,000; Full time

Benefits offered by this job

Discretionary annual bonus

Benefits package

Job summary

Roche Tissue Diagnostics in Arizona is seeking an Associate Systems Engineer to drive requirements engineering, risk management, and verification and validation activities across projects, ensuring compliance with regulatory standards.

You will collaborate with R&D, Quality, Regulatory, and Operations teams to define system architectures, manage risks, and deliver traceable validation criteria, contributing to the development of state-of-the-art diagnostic solutions.

Qualifications

• Bachelor's degree in engineering, biomedical sciences, or related field with 2 years of experience preferred.
• Regulatory familiarity with FDA, ISO and other standards for diagnostics products.
• Experience working in risk management and verification & validation within regulated environments.
• Experience with Retina tool for risk analysis and requirement work.

Responsibilities

• Define requirements, perform risk analysis, and plan verification & validation activities.
• Collaborate with R&D, Marketing, Operations, Quality, and Regulatory teams to ensure alignment with regulatory requirements.
• Drive traceability, risk mitigation, and validation criteria across projects.
• Analyze complex technical challenges and present solution options for stakeholders.

Skills

Requirements engineering

Risk management

Verification & validation

Cross-functional collaboration

Regulatory familiarity

RETINA tool

Education

Bachelor's degree in Engineering, Biomedical Sciences, or related field

Tools

RETINA tool

Job description

Roche Tissue Diagnostics in Arizona is seeking an Associate Systems Engineer to drive requirements engineering, risk management, and verification and validation activities across projects, ensuring compliance with regulatory standards.

You will collaborate with R&D, Quality, Regulatory, and Operations teams to define system architectures, manage risks, and deliver traceable validation criteria, contributing to the development of state-of-the-art diagnostic solutions.