Principal Software Quality Assurance Engineer (Remote - United States)

Solventum is a new healthcare company focused on improving lives through innovative solutions. As a Principal Software Quality Assurance Engineer, you will lead software assurance activities throughout the medical device software life cycle, ensuring compliance with regulatory requirements and acting as a quality champion in software development and testing teams.

Responsibilities:

• Leading software assurance activities throughout medical device software life cycle, including creating software quality assurance plan, determining software safety classification, software test readiness, software release readiness. Responsible for ensuring traceability upwards to system level requirements and safety/security risk controls as well as downwards to software design, implementation and testing
• Being an active member of the software team during the whole software life cycle, with responsibility for physical and functional configuration audits, reviewing and approving software requirements, software architectural and detailed design, test procedures, test logs, test results, and providing insight to management regarding software project status and software quality metrics
• Ensuring compliance with applicable regulatory requirements and industry standards; performing gap assessments; immediately elevating to management any major problem with device software that could affect patient safety, cyber security, customer usability or system adherence to process requirements
• Acting as a quality champion in software product development and testing teams
• Supporting other software related processes such as CAPA process, and other quality related processes regarding cybersecurity risk management and software quality assurance

Requirements:

• Master's degree or higher in Computer Science, Software Engineering, Computer Engineering, Electrical Engineering, Cyber Security, or Information Science (completed and verified prior to start) and five (5) years of experience in software quality assurance in medical device, aerospace, or automotive industry
• OR
• Bachelor's degree in Computer Science, Software Engineering, Computer Engineering, Electrical Engineering, Cyber Security or Information Science (completed and verified prior to start) and seven (7) years of experience in software quality assurance in medical device, aerospace, or automotive industry
• Working knowledge of premarket and postmarket medical device regulations (FDA, EU and other agencies), as well as medical device related standards, such as ISO 13485, ISO 14971, IEC 62304, IEC 81001-5 series amongst others
• Experience developing and testing software systems, SaMD, SiMD, and/or embedded software and creating appropriate documentation
• Knowledge of Software Engineering best practices and working knowledge of C language preferred
• Experience with embedded systems, IoT, Bluetooth, wi-fi and cellular technologies
• Excellent verbal and written communication skills, strong problem-solving ability, and attention to detail
• Ability to effectively manage multiple simultaneous tasks and priorities and perform under a dynamic environment with parallel product releases and multiple project teams
• Ability to deal effectively with other employees and external business contacts while conveying a positive, service-oriented attitude