Software Quality Engineer (Medical Devices)

Software Quality Engineer (Medical Devices)

REMOTE role

The Software Engineer will focus on software-specific design controls, conducting gap assessments and remediation for Design Inputs, Design Outputs, V&V, and Risk Management related to the device's software components to meet FDA and IEC 62304 requirements.

Responsibilities

Assess and remediate software requirements, architecture, and detailed design documentation.

Support software risk analysis and integration into the overall device risk management file.

Develop or update unit/integration verification protocols and traceability.

Identify cybersecurity and usability gaps in software design outputs and recommend

mitigations.

Ensure software lifecycle documentation aligns with Design Transfer readiness

Qualifications

Degree in Software Engineering, Computer Science, or related field

Medical device software development experience under IEC 62304 and 21 CFR 820

Proficiency with software design controls, requirements management, and risk management

tools

Experience in software gap assessments or remediation projects

Familiarity with FDA cybersecurity guidance and usability engineering

Interested or know someone? Email here kiran.o@intellectt.com