Labeling Engineer

• Creates, reviews, and reproduces product text for medical products labeling and Instructions for use (IFU), patient or promotional printed components, and/or capital equipment manuals.
• Ensures all product text for product labeling, IFU's, and equipment manuals meet all required legal, regulatory, clinical, marketing, packaging engineering, manufacturing (both inter and outer company) and R&D requirements through the use of corporate labeling guidelines and SOP's.
• Establishes parameters to introduce new products into the corporate master brand (MB).
• Works with packaging engineer to establish sub-team for MB introduction on qualifying new product releases.
• Work cross-functionally with project management, quality, R&D, manufacturing, regulatory, operations, and marketing to ensure project success.

• Bachelor’s degree in Science/Commerce/Arts or Technology with relevant experience
• Three to five years of Labeling and Graphic Designing experience. Regulated industry (Pharmaceutical/ medical device) related experience preferred
• Knowledgeable in HIBCC bar code standards preferred. Software utilized includes Adobe InDesign, Adobe Illustrator, Adobe Photoshop, Easy Label, Bar One, Bar Tender, and Label Matrix
• Strong communication skills (oral, written, and virtual)
• Demonstrated problem solving capability
• Quality-driven with great work ethic, highly motivated, tenacious, and meticulous in execution
• Strong attention to detail; ability to manage simultaneous projects and timelines effectively

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

• Not applicable.

Knowledge

Applies limited knowledge of business concepts, procedures and practices and a basic understanding of department fundamentals.

Cognitive Skills

Performs routine tasks working from detailed written or verbal instructions.

Supervision Received

Close supervision. Receives detailed instruction on all assignments and constant checking of work performance.

Consequence of Errors

Errors can be easily and quickly detected within the immediate work unit and would result only in minor disruption or expense to correct.

Contacts

Contacts are primarily within immediate work unit.  Contacts involve obtaining or providing information requiring little explanation or interpretation.