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Labeling Engineer

Labeling Engineer

GForce Life SciencesSunnyvale, CA, United States
12 hours ago
Job type
  • Temporary
Job description

Labeling Engineer - Design Verification

6 month contract

Must be able to work on a W2

On-site in Sunnyvale, CA

Roles and 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
  • Passionate about achieving first-time-right results

Other responsibilities :

  • 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

    • Technical skills

  • 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. Strong 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
  • Comfortable making risk-based decisions, interpreting regulations, and explaining and justifying strategies based on quality systems

    • Other skills and abilities

  • Able to learn and apply established procedures in a reliable and consistent manner
  • Strong leadership, negotiation, interpersonal, communication, and facilitation skills
  • Ability to lead and deliver in a matrix organization environment
  • Excellent written and verbal communication skills with the ability to work effectively across departments and influence stakeholders
  • Strong problem-solving skills and ability to be self-managed in a fast-paced environment utilizing agile / sprint methodologies
  • Proficient with MS Office applications, including Word, Excel, Outlook, and Teams
  • Travel ~10% Intl / domestic
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    Engineer • Sunnyvale, CA, United States