Principal Software Quality Engineer

Seeking a Senior Software Quality Engineer to serve as a technical quality leader supporting software-enabled and connected medical device systems. This role partners closely with Software Engineering Systems Engineering Manufacturing and cross-functional teams to ensure compliant secure and high-quality product development throughout the software lifecycle.

Key Qualifications:

• Bachelors degree in Computer Science Software Engineering Biomedical Engineering or related field
• 5 years of experience in software quality software validation software development or a regulated industry (medical device pharma etc.)
• Strong understanding of Software Development Lifecycle (SDLC) Design Controls verification & validation and risk management
• Experience with software validation traceability requirements management and test execution
• Knowledge of ISO 13485 ISO 14971 IEC 62304 usability engineering and cybersecurity principles
• Experience supporting QMS tools change control software releases and audit readiness
• Strong analytical documentation problem-solving and cross-functional communication skills

This is an excellent opportunity for a quality professional who enjoys working at the intersection of software quality regulatory compliance and connected healthcare technologies helping to drive product quality and continuous improvement across the development lifecycle.

Remote US role; preference in/around Chicago or WI for site visits.

Comp: $110-140k base salary plus 15% bonus