Label Content Manager

Job Summary:

The Label Content Manager is responsible for creating and designing the content and layout of medical device documentation and labeling and analyzing and developing content to ensure new entries comply with regulatory requirements. The Label Content Manager writes and implements code to create label content. This position will have the responsibility for label creation with a primary focus on variable information labels printed on the production line. Additionally, this person will manage projects which may involve collaborating with multiple contributors throughout the company on large scale projects. This position also oversees and manages maintenance of the large database of control documents related to all aspects of medical device packaging.

Duties & Responsibilities:

• Create and design content and layout of medical device documentation and labeling.
• Develop, write code, and implement custom Visual Basic Script solutions within BarTender software to enhance label design, functionality, and printing processes, improving operational efficiency.
• Analyze and write label content to ensure compliance with regulatory requirements.
• Supervise and manage projects involving collaboration with multiple contributors throughout the company on large scale projects.
• Create and maintain final product packaging drawings and Bill of Materials (BOM) that accurately represent the product's components and packaging requirements.
• Collaborate with cross-functional teams and external vendors to coordinate project timelines and deliverables, ensuring projects are executed on schedule and align with company objectives.
• Identify opportunities to streamline processes, reduce waste, or improve efficiency in labeling and packaging operations to support cost reduction projects.
• Oversee and manage new label material or sizes with outside vendors, ensuring that all materials meet required quality and regulatory standards.
• Primary responsibility for label creation with focus on variable information labels printed on the production line.
• Develop and manage label documentation to accurately convey product information and ensure compliance with regulatory requirements.
• Oversee development and maintenance of a comprehensive database of Global Trade Item Number (GTIN) for all products.

• Review translations for labels intended for markets, ensuring content accuracy and regulatory compliance.

• Manage country-specific labels and coordinate language translations for packaging labels to meet regional regulatory standards and quarterly revenue targets.
• Manage label stock material specifications, collaborating with manufacturing teams to ensure materials meet project requirements.

• Troubleshoot printer and barcode scanner issues with manufacturing teams to maintain operational efficiency.

• Review and approve First Article Inspection (FAI) and Non-Conformance reports related to packaging and label materials to maintain quality standards.

• Role may involve global responsibilities pertaining to the above listed duties

• Perform additional duties or special projects as assigned, contributing to continuous improvement initiatives within the labeling department and organization wide.

Minimum Qualifications

• Experienced user on the latest versions of AutoCAD or Solidworks
• Experienced user on Adobe Illustrator
• Working knowledge of barcode/label creation software (eg. BarTender)

• Familiar with Agile or equivalent automated product lifecycle management system

• Experience in packaging of instruments, electronics or medical products; (or another regulated products industry)
• Experience with database and documentation systems
• 3+ yrs experience overseeing packaging and labeling projects from design to production

• Portfolio of various packaging labeling projects

Preferred Qualifications:

• 3+ years developing and managing label documentation for a medical company

• Proven expertise in Adobe Illustrator, and a working knowledge of Photoshop

• Expert in latest versions of AutoCAD or Solidworks with an emphasis on drawing creation

• Experience in PC and Apple/Mac is a plus

• Experience with Bartender (barcode label software)

• Experience managing custom label development with outside vendors

Education:

• B.S. Degree in packaging/labeling design or related field, or equivalent.

Compensation + Benefits: The anticipated range for this position is $60,000 - $80,000. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience. Masimo offers benefits such as Medical, Dental, Vision, Life/AD&D, Disability Insurance, 401(k), Vacation, Sick, Holiday, Paid Maternity Leave, Flexible Spending Accounts, voluntary Accident, Critical Illness, Hospital, Long-Term Care, Employee Assistance Program, Pet Insurance, on-site Wellness Clinic, Fitness Center, Cafe. All benefits are subject to eligibility requirements.

Physical requirements/Work Environment:

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver's license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.