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, Position Overview The Quality Engineer plays a key role in ensuring that our products, processes, and systems meet regulatory, customer, and internal quality standards. This role …

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

Dentsply Sirona is the world's largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and p… + 1 month ago, © 2026 Careerjet All rights reserved