Principal Labeling Engineer - Shockwave Medical

Johnson & Johnson Innovative Medicine • Santa Clara, CA

2d • Onsite

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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. 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.

Requirements

• Bachelor’s degree in Engineering (mechanical, biomedical, manufacturing, industrial or related technical discipline); advanced degree preferred.
• 10+ years, or 8 years with a Master’s Degree, in medical device manufacturing, labeling engineering, packaging automation, or related engineering functions; experience leading labeling system design and validation.
• Expertise in label printing technologies, serialization/UDI, barcode symbologist, design controls, software/hardware validation, and regulatory labeling requirements.
• Strong systems and strategy thinking, advanced technical troubleshooting, project leadership, ability to translate regulatory and business needs into engineered solutions.
• Proficiency with PLM/ERP/MES integrations, label design/printing software (e.g.,Loftware, NiceLabel, Bartender), and test/validation documentation tools.
• Ability to work in a fast-paced environment, manage multiple priorities, and operate both independently and collaboratively while demonstrating flexibility to changing requirements.

Nice To Haves

• Coaching
• Competitive Landscape Analysis
• Critical Thinking
• EHS Compliance
• Engineering
• Good Manufacturing Practices (GMP)
• Lean Supply Chain Management
• Organizing
• Package and Labeling Regulations
• Package Management
• Process Improvements
• Product Packaging Design
• Science, Technology, Engineering, and Math (STEM) Application
• Standard Operating Procedure (SOP)
• Sustainability
• Sustainable Packaging
• Transparency Reporting
• Validation Testing

Responsibilities

• 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.

Benefits

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits:
• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Number of Employees: 5,001-10,000 employees