Senior Packaging and Labeling Product Engineer

Company: Align Technology, Inc.
Location: Campbell
Posted on: January 7, 2026

Job Description:

The Senior Packaging and Labeling Product Engineer will lead critical packaging and labelling initiatives. This role is essential for driving compliance, innovation, and operational excellence for Global Medical Device. If you have expertise in quality systems, regulatory compliance, project management, and process improvement, we want to hear from you. This role will be located in San Jose, CA and have no direct reports. Role expectations • Quality Systems Oversight: o Maintain and enhance packaging and labelling quality systems in compliance with Global Regulatory and Legal requirements. o Develop and refine SOPs, work instructions, and other quality documentation. • Change Management: o Lead change management for packaging and labelling, ensuring smooth implementation of lifecycle changes. o Review and manage label change requests (LCR) to ensure compliance and timely updates. o Manage packaging and labelling initiatives from concept to implementation. o Develop scopes, timelines, and risk mitigation strategies to ensure compliance with regulatory standards. • Process Improvement: o Identify opportunities for efficiency within labelling workflows and implement best practices. o Drive continuous improvement to enhance compliance, productivity, and cost-effectiveness. • Technical Support and Troubleshooting: o Provide expertise in root cause analysis and corrective actions for packaging and labelling issues. o Ensure specifications meet regulatory and process standards. • Cross-Functional Collaboration: o Collaborate with quality assurance, regulatory affairs, manufacturing, engineering, operations, product management, PMO, and supply chain teams. o Support product launches and regulatory updates to achieve timely and compliant product releases. o Travel ~30% What were looking for • Education: Bachelor’s degree in Engineering, Regulatory Affairs, or a related field. • Experience: Minimum 6 years of experience in global medical device and/or pharmaceutical packaging and labelling. • Regulatory Knowledge: Deep understanding of global regulatory, legal, and carrier compliance standards. • Technical Skills: Expertise in quality systems, label equipment and related end to end systems, artwork review, and regulatory compliance. • Project Management: Proven ability to manage multiple projects effectively. • Communication Skills: Strong collaboration and influencing abilities across departments. • Experience with implementation and execution of program and enterprise risk management. • Familiarity with Root Cause Analysis and Operational Excellence methodologies such as LEAN, DMAIC, Six Sigma.

Keywords: Align Technology, Inc., Livermore , Senior Packaging and Labeling Product Engineer, Manufacturing , Campbell, California