Principal Labeling Engineer - Shockwave Medical

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Job Function:

Supply Chain Engineering

Job Sub Function:

Packaging Design Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Principal Labeling Engineer – Shockwave Medical to join our team located in Santa Clara, CA.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Principal Labeling Engineer leads the strategy, technical development, implementation, and maintenance of medical device labeling systems and processes, including label templates, automated printing/serialization systems, data pipelines (PLM/ERP), label validation/verification activities, design control documentation, and labeling risk assessments. This role leads technical initiatives to enhance labeling robustness, accuracy, and traceability.

The Principal Labeling Engineer partners with Regulatory Affairs, Quality, IT, Manufacturing, Supply Chain and external partners to drive scalable and compliant labeling solutions.

Essential Job Functions                 

• Own enterprise-level labeling process reliability to define mitigation strategies for recurring printing, applicator, label quality issues; and implement corrective and preventative engineering solutions across sites.

• Define labeling requirements and design inputs for new product development and design changes.

• Lead and oversee labeling change control activities in coordination with Regulatory Affairs, Quality, Manufacturing, and Supply Chain according to QMS system.

• Lead cross-functional labeling projects (e.g. new product introductions, technology upgrades, large-scale label updates, and special projects).

• Define vendor strategy for new or changes to current labeling materials, printers, software, and external labeling software vendors.

• Develop validation protocols and conduct verification/validation testing per QMS requirements.

• Maintain labeling documentation within PLM, ERP, or document control systems,

• Create, review, and proofread label content, including text, barcodes, symbols, and instructions for use (IFUs), ensuring correct accuracy and compliance with regulatory and formats and print specifications. 

• Manage the full labeling change- control lifecycle

• Define engineering standards and maintain technical work instructions, equipment specifications, and preventive maintenance plans for labeling equipment across sites

• Lead strategic continuous improvement automation initiatives to reduce manual work, improve data integrity and decrease labeling-related CAPAs.

• Act as primary labeling SME, delivering executive-level communications, developing remediation plans, and driving cross-site alignment.

• Provide technical leadership by mentoring Senior and Staff Labeling Engineers and contribute to hiring decisions.

• Perform other related duties as assigned. 

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