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

Contract work,