NPI Engineer- Hardware Test

Overview

The team in the final stages of pre-launch for an innovative medical device. This role is critical to ensuring product quality, patient safety, and regulatory compliance. Targeting experience in automated testing using Python, strong problem-solving skills, and familiarity with regulated environments (FDA, ISO 13485, IEC 62304).

Day to Day

• Design and maintain test procedures, TMPs, TMVs, and TPI documentation
• Support agile release cycles, ensuring testing readiness and quality gates are met
• Participate in verification and validation (V&V) activities to ensure system readiness for launch
• Develop test protocols and reports aligned with regulatory standards
• Modify and edit existing Python test scripts
• Perform functional, integration, system, and regression testing
• Automate test data generation, execution pipelines, and result validation
• Maintain traceability between requirements, test cases, and defects