SaMD Quality & Cybersecurity Engineer

Promaxo; Oakland (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

Promaxo is transforming MRI at the point of care with portable imaging platforms. The Software Quality Engineer will execute verification for connected software and cloud components, embedding quality and cybersecurity into the SDLC and QMS.

Responsibilities include risk analysis, defect triage, and collaboration with R&D to meet FDA/ISO requirements, while supporting postmarket cybersecurity activities and CAPA processes.

Qualifications

• 3+ years of software quality engineering experience in the medical device industry.
• Working knowledge of IEC 62304 and ISO 14971; exposure to FDA guidance is a plus.
• Experience with product cybersecurity testing and documentation including SBOM and vulnerability testing.
• Authorized to work in the United States.

Responsibilities

• Execute software verification for connected device software and cloud components, translating requirements into test plans and records.
• Develop and maintain verification plans and reports in compliance with FDA QMSR, ISO 13485, and IEC 62304.
• Support risk analysis, defect triage, and root-cause investigations for software issues.
• Participate in design and code reviews to ensure regulatory and quality expectations are met.
• Perform manual and automated testing across functional, integration, system, and regression tests.
• Log and triage defects in Jira and coordinate verification with software engineers.

Skills

Software quality engineering

Testing

Regulatory compliance

Cross-functional collaboration

Tools

Jira

Job description

Promaxo is transforming MRI at the point of care with portable imaging platforms. The Software Quality Engineer will execute verification for connected software and cloud components, embedding quality and cybersecurity into the SDLC and QMS.

Responsibilities include risk analysis, defect triage, and collaboration with R&D to meet FDA/ISO requirements, while supporting postmarket cybersecurity activities and CAPA processes.