Senior Software Quality Engineer - AI/MedTech, Regulated

Tempus; Chicago, Redwood City, New York (IL, CA, NY); Sur place; USD 120 000 - 165 000; Plein temps

Résumé du poste

Tempus, a leader in precision medicine, seeks a Senior Software Quality Engineer in Chicago to drive SDLC compliance for medical device software and SaMD. You will ensure DHF deliverables, requirements traceability, and risk management are maintained throughout the lifecycle.

The role requires 5+ years in software quality within FDA-regulated settings, with knowledge of FDA QMSR, ISO 13485, IEC 62304, and ISO 14971.

Qualifications

• 5+ years in a software quality role within FDA-regulated medical device/IVD (or EU MDR/IVDR).
• Familiarity with FDA QMSR, ISO 13485, IEC 62304, ISO 14971.

Responsabilités

• Support SDLC activities for medical device software ensuring Design and Development file (DHF) deliverables are generated and maintained.
• Maintain traceability across requirements, design, verification and validation.
• Manage Risk Management/FMEA and Cybersecurity considerations.
• Oversee CAPAs, NCRs, audits, management reviews and training.
• Collaborate with Product, Engineering, and Regulatory Affairs to ensure compliance.

Connaissances

Software quality

Regulatory knowledge

Quality systems

Risk management

Cybersecurity awareness

Formation

Bachelor's degree in Biomedical/CS/Software Engineering

Outils

eQMS

Description du poste

Tempus, a leader in precision medicine, seeks a Senior Software Quality Engineer in Chicago to drive SDLC compliance for medical device software and SaMD. You will ensure DHF deliverables, requirements traceability, and risk management are maintained throughout the lifecycle.

The role requires 5+ years in software quality within FDA-regulated settings, with knowledge of FDA QMSR, ISO 13485, IEC 62304, and ISO 14971.