Leading software assurance activities throughout medical device software life cycle
Creating software quality assurance plan
Determining software safety classification
Software test readiness and software release readiness
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
Responsibility for physical and functional configuration audits
Reviewing and approving software requirements, software architectural and detailed design, test procedures, test logs, test results
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.

Master’s degree or higher in Computer Science, Software Engineering, Computer Engineering, Electrical Engineering, Cyber Security, or Information Science 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 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)
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.

Principal Software Quality Assurance Engineer

Key skills