Staff/Principal Software Quality Assurance Engineer

Job Description

• Develop and execute detailed test plans and test cases to verify software functionality, reliability, and performance. • Author validation plans, protocols, software risk analyses for a medical device. • Conduct regular regression testing, analyze results, and work closely with the development team for timely issue resolution. • Manage and maintain bug tracking systems to document issues. • Support and investigate customers’ complaints related to product software. • Collaborate with users and developers to replicate and resolve bugs. • Provide guidance for cybersecurity. • Mange monitoring of software anomalies.

Qualifications

• Bachelor’s degree in Computer Science, Software/Electrical engineering. • Minimum of 7+ years of work experience in the medical device field. • Knowledge of complex Quality Engineering processes and regulatory requirements. • Excellent ability to apply a systematic and analytical approach to problem-solving. • Advanced knowledge and ability to apply core concepts of engineering. • Ability to interpret internal/external business challenges and make recommendations for improvements to products, processes or services. • Experience writing and executing validation/verification plans, protocols, and software risk analysis on Medical Devices. • Working knowledge of FDA, Software Validation Guidance, 21 CFR part 820, IEC 62304, and IEC 82304-1. • Experience in cybersecurity and Software Risks. • Lead and participate in project teams assigned to new products.

Benefits

• Not specified •