Software Quality Engineer - Medical Device

SARACA is seeking a Software Quality Engineer – Medical Device to ensure the quality and regulatory compliance of medical device software throughout the product lifecycle. The role establishes and maintains design quality processes, performs software reviews and verification and validation activities, supports risk management, and guides cross-functional teams on quality practices and compliance.

Responsibilities:

• Ensuring the quality and compliance of software used in medical devices throughout the product lifecycle
• Establishing and maintaining design quality processes aligned with IEC 62304, ISO 13485, EU MDR, and related standards
• Reviewing software requirements, architecture, and design documents; defining and executing verification and validation plans; and supporting risk management activities for software-intensive medical devices
• Performing design reviews, assessing test coverage and defect trends, and providing guidance to cross-functional teams on quality best practices
• Collaborate closely with R&D, regulatory, and project stakeholders to drive continuous improvement in software product quality, documentation, and compliance

Requirements:

• 10+ years of experience in regulated Medical Device Software environments
• Software Design Assurance & Design Controls
• SDLC Quality & Software Risk Management
• IEC 62304, ISO 14971, FDA QSR & Medical Device QMS
• Software V&V, requirements traceability, design & architecture reviews
• Connected and embedded medical systems
• CAPA, RCA, Non-Conformance & Design for Quality
• Agile / SAFe experience
• Regulatory submissions and audit support
• Ability to interpret C, C++, C#, or similar object-oriented programming languages
• Bachelor's degree in Software Engineering, Computer Engineering, Systems Engineering, Biomedical Engineering, Electrical Engineering, or related field
• Master's degree preferred
• ASQ CQE, CSQE, or Six Sigma certification is a plus