Associate Systems Engineer: Drive V&V & Risk in Diagnostics

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

Job summary

Roche Tissue Diagnostics seeks an Associate Systems Engineer to drive requirements, risk management, and verification & validation within IVD projects. You will own deliverables, design architectures, and ensure regulatory alignment across R&D, Quality, and Regulatory teams.

The role emphasizes analyzing risks, engaging stakeholders, and delivering robust validation criteria while supporting traceability and defect management.

Qualifications

• Educational background in engineering/biomedical sciences with 2 years of experience preferred.
• Experience in assay development at a medical device company.
• Regulatory familiarity with FDA, ISO and diagnostics standards.
• Strategic mindset with understanding of IVD landscape and validation approaches.
• Experience using RETINA tool for risk analysis and requirement work.

Responsibilities

• Apply Systems Engineering across requirements engineering, risk management, and V&V.
• Research industry trends and emerging technologies for robust validation strategies.
• Collaborate with R&D, Marketing, Operations and Quality for regulatory alignment.
• Engage with VoC to align solutions with customer needs and market demands.
• Provide multiple solution paths for requirements, risk and validation challenges.
• Execute project deliverables in requirements engineering, risk analysis, and V&V tasks.

Skills

Regulatory knowledge

Requirements engineering

Risk analysis

Traceability

Cross-functional collaboration

Education

Bachelor's degree in Engineering/Biomedical Sciences

Tools

RETINA tool

Job description

Roche Tissue Diagnostics seeks an Associate Systems Engineer to drive requirements, risk management, and verification & validation within IVD projects. You will own deliverables, design architectures, and ensure regulatory alignment across R&D, Quality, and Regulatory teams.

The role emphasizes analyzing risks, engaging stakeholders, and delivering robust validation criteria while supporting traceability and defect management.