Role name: Junior Test Engineer
Work Location: Andover MA (Onsite)
Key Responsibilities
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