Labeling Engineer

Position Summary

The Labeling Engineer will first be responsible for driving end to end execution of labeling development that involves product development, regulatory, compliance, and supply chain strategies for both new and commercialized products. They will do so as part of the Research and Development team and participate in other design and project activities as needed.

Key Accountabilities

• Responsible for labeling project portfolio management across new product development and lifecycle management to support on time launches and design change implementation.
• Responsible for executing labeling design change projects resulting from feature improvements, part obsolescence, requirement changes, etc.
• Drafting and releasing document updates including test reports, requirements, drawings/BOMs, etc.
• Technical writing including User Manual/IFU drafts, requirements, procedures, test protocols and results, and project updates.
• Accountable for completing Design Control documentation and execution for label development and R&D projects.
• Responsible for completion of all steps of the labeling process including change assessments, redlines of IFU/artwork, release, and implementation.
• Coordinate with external partners to translate labeling to support global distribution of products.
• Work with planning for phase in/phase out of changes considering commercial, quality, or regulatory strategies and ensure timely implementation.
• Lead and/or support Nonconformances /CAPAs related to labeling and R&D as needed.
• Assist in other product development activities including but not limited to: vendor identification, assessment, and management as well as procurement.
• Know & follow local Quality System policies & procedures.
  
  

Education, Experience & Skills

• A minimum of a Bachelor's Degree in Engineering or equivalent is required.
• A minimum of 2 years of related experience is required. At least 1 year of medical device labeling experience is desired.
• Understanding of compliance and regulatory requirements for medical devices and labeling.
• Understanding of manufacturing, packaging, and labeling processes within a regulated field.
• Experience with Solidworks or equivalent CAD preferred.
• Experience with Adobe Illustrator or equivalent preferred.
• Strong interpersonal and influence skills.
• Excellent communication and presentation skills.
• Ability to lead multiple assignments or projects with sound analytical and problem-solving skills.
• Excellent planning and organization skills.
  
  

Physical Requirements

• Sit or stand for 8-10 hours per day.
• Lift up to 20 lbs.
• Specific vision ability required by this job include close and distance vision, color, depth perception and ability to adjust focus.