IVD Systems Engineer — R&D & Validation

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

Job summary

Roche seeks an Associate Systems Engineer to join the R&D team in Arizona. You will drive requirements definition, risk management, and verification & validation activities for IVD systems, ensuring traceability and regulatory compliance.

You will own project deliverables and collaborate with multiple functions to deliver robust solutions. The role emphasizes cross-functional collaboration, lifecycle management, and risk-driven decision making, with an eye toward patient-centered diagnostic

Qualifications

• Bachelor's degree in Engineering, Biomedical Sciences, or related technical field with 2 years of experience preferred.
• Experience in assay development at a medical device company.
• Familiarity with FDA, ISO and regulatory standards for diagnostics products.
• Experience with risk analysis and validation in IVD context.

Responsibilities

• Define requirements engineering, risk analysis, and verification & validation.
• Perform system lifecycle management and risk mitigation.
• Collaborate with R&D, Marketing, Operations, Quality, and Regulatory teams.
• Engage with VoC representatives to align technical solutions with customer needs.
• Provide multiple solution paths and decision support for validation criteria.

Skills

Requirements engineering

Risk analysis

Traceability

Verification & validation

Regulatory familiarity

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Biomedical Sciences

Tools

RETINA tool

Job description

Roche seeks an Associate Systems Engineer to join the R&D team in Arizona. You will drive requirements definition, risk management, and verification & validation activities for IVD systems, ensuring traceability and regulatory compliance.

You will own project deliverables and collaborate with multiple functions to deliver robust solutions. The role emphasizes cross-functional collaboration, lifecycle management, and risk-driven decision making, with an eye toward patient-centered diagnostic