Design Verification Engineer Labeling

Design Verification Engineer Labeling

Requirements

• Minimum of bachelor’s degree in engineering, or a related field
• Minimum of 4 years of experience working in labeling, hardware, system production, or test environment primarily as Verification Engineer in the medical device industry

Responsibilities

• Generate and take ownership of test protocol design, strategy, test execution, trace matrix, test report, artifacts, and related activities
• Perform all upstream and downstream requirements tracing using tools such as Polarion or equivalent
• Develop and execute test protocols for product labels
• Clearly document test results and observations in test reports
• Review and recommend improvements to test methods, leverage/incorporate industry best practices, collaborate with cross-functional partners and adhere to quality standards
• Identify and present problems that arise during feasibility and design verification testing, and escalate new or persistent failure modes to appropriate engineering teams
• Proactively engage with engineering teams on failure investigation and root cause analysis
• Manage and qualify all lab test equipment
• Perform a broad variety of tasks in support of label verification and process design established by departmental goals
• Deep understanding of design controls processes related to verification and validation
• Perform equipment validation as required (IQ/OQ/PQ)
• Ensure successful, on-time completion of department projects; communicate constraints to direct management when successful project completion is at risk
• Own label verification deliverables for assigned projects as the Subject Matter Expert (SME)
• Actively contribute to core team meetings by providing insights, and updates on project deliverables, ensuring alignment with overall project goals
• Collaborate closely with Packaging and Test Engineering teams to drive seamless integration, troubleshoot issues, and ensure compliance with quality and performance standards

Preferred Qualifications

• Working knowledge of tools for label development such as Robar, Prisym360, Bartender, PLM (Agile), issue tracking (Jira), and software testing (Qtest) is preferred
• Experience with Polarion or other equivalent requirements tracing software is a plus
• Experience working in a regulated industry is preferred
• Proven understanding of medical device standards including ISO, FDA, GDP, and GMP guidelines is preferred
• Prior experience with labeling equipment, such as thermal transfer printers, Form-Fill-Seal (FFS) systems, and UV laser markers is a plus