Sr Eng RD Soft Eng

Senior Quality Engineer for medical device software development at Johnson & Johnson, providing quality leadership on product teams. Responsible for requirements gathering, risk assessments, test strategies, design controls, and regulatory compliance for SaMD and medical device software systems.

Responsibilities

• Lead quality and design control activities for medical device and SaMD product development
• Facilitate requirements refinement, risk assessments, and test strategy development with R&D teams
• Oversee verification documentation, code reviews, test execution, and defect management
• Support regulatory filings, audits, and non-conformance investigations
• Train and mentor quality engineers and provide compliance guidance to project teams and suppliers

Requirements

• Bachelor's degree in Engineering, Computer Science, or Biomedical Engineering
• Minimum 4 years regulated industry experience in quality or product development
• Medical device industry experience required
• ASQ Certification as Software Quality Engineer preferred
• Knowledge of IEC 62304, FDA guidance, ISO 13485, EU MDR, and related standards
• Proficiency with Microsoft Office and quality management tools
• Strong project management and prioritization skills