Software Quality Engineer

Seeking a Sr Software Quality Engineer to support medical device software and system development within a regulated environment. The ideal candidate will have strong software engineering knowledge along with experience in design controls, software risk management, and verification & validation., * Provide quality oversight throughout the software/system development lifecycle.

• Support software requirements, design reviews, risk assessments, and V&V activities.
• Ensure compliance with applicable quality and regulatory requirements.
• Partner with Engineering, Quality, Regulatory, Clinical, and Product Development teams.
• Support root cause analysis, corrective actions, and continuous improvement.

• 5+ years of relevant experience in Software Quality, Software Engineering, Systems Engineering, or Design Assurance.
• Bachelor’s or master’s degree in engineering or related technical field.
• Hands-on software coding experience with C, C++, Java, Python, or similar.
• Strong experience with Software Risk Assessment/Risk Management.
• Experience with Software Verification & Validation (V&V).
• Knowledge of Design Controls, requirements traceability, and software lifecycle activities.
• Medical device or other regulated-industry experience preferred.
• Knowledge of IEC 62304, ISO 14971, ISO 13485, and FDA design control requirements is a plus.
• Strong communication and cross-functional collaboration skills.