Hollister Incorporated is operating in a hybrid working environment.
Responsibilities:
Author and/or coordinate the development of technical labeling documentation, including labeling specifications, change controls, design transfer checklists, protocols, s, and original data.
Specify barcode requirements, folding patterns, ink colors, labeling dimensions, etc. for labeling material specifications in collaboration with the Labeling Content Specialists, Labeling Developers, and/or Graphic Designers.
Lead the Labeling Technical Development (LTD) assessment during the development of new or revised labeling, packaging artwork, and instructions for use.
Perform labeling qualification studies in collaboration with Global Packaging, Sterility Assurance, Biocompatibility, Manufacturing, Supplier Quality, and other functions as applicable.
Develop subject matter expertise on all relevant labeling standards for labeling legibility, durability, and performance.
Lead change control projects for simple to complex labeling changes that may or may not require verification and/or validation.
Explore, support, and lead the implementation of new technologies for labeling development and production, e.g., Global Enterprise Labeling System, QR codes for eIFU, IFU printing on-demand, packaging artwork printing on-demand, RFID, etc.
Explore, support, and lead labeling cost savings initiatives, e.g., label stock consolidation, IFU page size consolidation, ink color consolidation, inline barcode verification, etc.
Effectively apply advanced knowledge under general guidance on concepts, principles, and technical capabilities for projects of varying scope and complexity.
Collaborate cross-functionally with global team members across time zones within Hollister and with global partners.
Work independently with minimal direction.
Note: This is not an exhaustive list of duties or functions and may not comprise of all ‘essential functions’ necessary to perform this role. (for ADA purposes)
Essential Functions of the Role**:
Use of computer and accessories (monitor, keyboard, mouse)
Periodic global travel to manufacturing plants, distribution centers, suppliers, or laboratories to coordinate testing
Work Experience Requirements:
Number of Overall Years Necessary: 5-8
Engineering experience with labeling and/or packaging projects
Medical device or other healthcare industry experience preferred
Education Requirements:
Bachelor’s degree in engineering, science, or technology; Packaging degree preferred
Specialized Skills/Technical Knowledge:
Proficient in Microsoft Office (Outlook, Excel, PowerPoint and Word).
Experience with labeling printers, barcode verifiers, and labeling test equipment, e.g., Sutherland Rub Tester, Instron, etc.
Strong technical writing skills and interpersonal communication (both written and oral).
Knowledge and understanding of global medical device labeling regulations and standards.
Exceptional attention to detail, excellent follow-up, multi-tasking and organizational skills, clear and concise oral and written communication skills, and ability to work effectively with global team members across time zones in a hybrid work arrangement.
Problem-solving skills including the ability to analyze all aspects of a situation, identify potential solutions, make informed decisions, and implement the solution in a timely manner.
Local Specifications (English and Local Language):
Fluent in English (written and oral)
Labeling Engineer
Job Segment: Technical Writer, Technology