Software Quality Validation Engineer (Medical Devices) - Only On W2

Major Duties

·        Support software verification & validation (V&V) activities (test protocols, plans, reports), including non-product software assessment.

·        Support product cybersecurity assessments in collaboration with cross-functional teams.

·        Review software and system documentation to ensure quality and compliance.

·        Maintain requirements traceability and support SDLC processes.

·        Perform risk assessments (FMEA, hazard analysis) and drive issue resolution.

·        Participate in sustaining engineering activities, including post-release support and issue resolution, may participate in design reviews and represent Quality in approvals.

·        Support post-release changes, audits, and quality system improvements.

·        Collaborate cross-functionally to ensure compliance with FDA, ISO 13485, IEC 62304.

Education and Experience:

·        Minimum Bachelor’s degree in Computer Science, Software Engineering, Systems Engineering, or a related technical field.

·        Minimum 2 years of experience in software quality, validation, systems engineering, or a related discipline.

·        Experience working in a regulated industry (medical device, diagnostics, pharmaceutical).

·        Self-motivated with the ability to work independently with minimal supervision. Strong analytical, communication, and teamwork skills.

·        Experience in audit setting preferred.