Principal Engineer, Software Quality
Becton Dickinson & Co
Principal Engineer role focused on software quality assurance for medical device software at a global medical technology company. Responsible for developing QA strategies, leading testing initiatives, and ensuring compliance with FDA and ISO standards throughout the software development lifecycle.
Responsibilities
- Develop and maintain comprehensive software QA strategies, plans, and procedures aligned with regulatory requirements
- Lead review and execution of test plans, test cases, and automation scripts for embedded, application, and cloud-based software
- Develop risk management files and perform risk analysis for software and system-level defects
- Lead defect management, design reviews, and root cause analysis with development teams
- Drive continuous improvement initiatives in quality processes, tools, and metrics while mentoring junior engineers
Requirements
- Bachelor's or Master's degree in Computer Science, Software Engineering, or related field
- Minimum 10 years software quality assurance experience; 5+ years in lead or principal role
- In-depth knowledge of FDA 21 CFR Part 820, ISO 13485, and IEC 62304 standards
- Strong understanding of SDLC methodologies in regulated environments
- Excellent analytical, problem-solving, and critical thinking abilities
- Strong written and verbal communication skills with cross-functional collaboration ability
- Polarion ALM system experience preferred
Vacancy posted 5 days ago
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