Description
Responsibilities will include:- Advise on efficient packing processes, procedures, innovations in packaging materials as improvement opportunities
- Make recommendations to resolve technical issues and to define their requirements
- Develop sketches, specifications, samples, and written analyses of packaging proposals in order to present design for approval
- Test, analyze, and select materials for packaging based on Branding project requirements and goals (Challenge testing and DOE)
- Develop and execute packaging validation protocols in compliance with EU Medical Device Directive, FDA, and other global regulatory requirements including IQ/OQ/PQ activities, simulated distribution and handling testing, sterility, and shelf life validation
- Develop, implement, and maintain packaging specifications, materials specifications, label specifications and packaging bill of materials
- Consult with Branding team, R&D, purchasing, and production to determine costs and feasibility of proposed changes
- Write finished goods and packaging ECO's - Includes; first article and/or special inspections, updating drawings, creating new SKU's, and developing tables to include new packaging components configurations.
- Implement all new packaging artwork for all SKU's
- Prepare and evaluate samples for design evaluation, testing, verification, and validation
- Update existing procedures, test methods, and photo documentation including the preparation of illustrations
Candidates for this position must have the following skills and experience:
- Bachelor's degree in Packaging Engineering, Packaging Science, or Mechanical Engineering
- 5-8 years of experience as a Packaging Engineer in a regulated field. Strongly desire medical industry.
- Knowledge of ISO, ASTM and ISTA Packaging Standards
- Knowledge of Windows, Microsoft Office, MS Project, and one or more drawing programs (Solidworks, Auto CAD, Adobe Illustrator, or similar programs)
- "Certified Packaging Professional" issued by the Institute of Packaging Professionals desired
- Attention to detail, hands-on, and self-motivated
- Ability to organize all device specific data for multiple SKU's creation
- Experience writing ECO's, updating drawings
- Experience implementing packaging and device branding changes with off-site facilities
Apply now for immediate consideration or contact Tom Bakker on for further details.
To find out more about Real please visit www.realstaffing.com