Execute System Verification & Validation: participate in developing and executing comprehensive est strategies for complex systems, ensuring alignment with product requirements and regulatory standards.
Participate in authoring and managing verification plans, protocols, test cases, traceability matrices, and summary reports.
Traceability: Ensure traceability between requirements, test protocols, and results to support regulatory submissions and audits.
Defect Management: Identify, report, and track hardware/software defects using tools like JIRA; validate fixes and support root cause analysis.
Cross-Functional Collaboration: Work closely with systems engineers, software and hardware teams, and global stakeholders to ensure seamless integration and testing.
Regulatory Compliance: Ensure traceability between requirements, test protocols, and results to support FDA, EU MDR, and ISO 13485 submissions.
Experience:
3+ years of experience in medical device verification & validation testing
Tools Experience: Jira, Cockpit, Windchill, or other requirements management, test management, and work management tools.
Outstanding communication, facilitation, and coaching skills
Authoritative knowledge in SCRUM, or related Agile frameworks and methodologies
Experience with product development involving hardware, firmware, and software elements
Experience presenting to executive level management on project status
Numbers & Facts
Location
Andover, MA
Salary
$50–$55 Per Hour
Skills
Agile Programming Methodologiesunmatched
Atlassian JIRAunmatched
Bug Tracking Softwareunmatched
Bug Tracking/Defect Managementunmatched
Coachingunmatched
Computer Firmwareunmatched
Cross-Functionalunmatched
FDA (Food and Drug Administration)unmatched
Hardware Debuggingunmatched
ISO (International Organization for Standardization)unmatched
Integration Testingunmatched
Medical Equipmentunmatched
Product Developmentunmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
Regulatory Submissionsunmatched
Requirements Managementunmatched
Root Cause Analysisunmatched
Scrum Project Management and Software Developmentunmatched
System Validationunmatched
Systems Engineeringunmatched
Test Caseunmatched
Test Requirementsunmatched
Testingunmatched
Traceabilityunmatched
Validation Testingunmatched
Verification Plansunmatched
Windchill PLM Softwareunmatched
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