Engineer II, Packaging - Defined Term

Getinge•Wayne, NJ

About The Position

This position is responsible for the development of sterile medical device packaging & labeling systems including heat sealing, transportation testing, bar-coding, direct part marking and thermal transfer printing. In this role, the individual will work with a variety of materials such as Tyvek, laminate films, corrugate as well as on multiple packaging projects with direction from Sr Manager, Package Engineering. Projects can encompass packaging design from concept stage to manufacturing in support of package improvements, material changes, process support (IQ/OQ/PQ).

Requirements

B.S. in Packaging Engineering or related technical degree.
3+ years package engineering experience in medical device industry.
Experience regulatory standards in medical device packaging primarily ISO 11607-1&2 in addition to associated test standards such as ASTM D4169, ISTA, FED-X, and package integrity TM’s.
Experience in healthcare labeling systems with GS1 bar-coding standards.
Excellent written and oral communication skills

Nice To Haves

Solid Works or other CAD based drawing program experience a plus.
Packaging materials knowledge related to Tyvek, thermoformed trays, packaging films, paperboard and the impact of various sterilization methods.
Knowledge of statistical applications

Responsibilities

Supports development of detailed validation documentation including package performance protocols, process validations, and accelerated aging studies in compliance with industry regulations.
Prepare specifications for packaging systems and evaluate existing specs for improvements for ease of understanding and compliance.
Provides technical development support for in-house thermal transfer labeling systems including bar-coding and direct part marking.
Works closely with Manufacturing, Purchasing, Marketing, QA, and Regulatory.
Works independently to plan and schedule own activities necessary to meet project timelines.
Designs and coordinates the implementation of new tooling and fixtures to support packaging operations.
Utilizing problem solving techniques to overcome technical issues.
Summarizes, analyzes, and draws conclusions from test results.
Trains production operators or technicians on new packaging equipment and processes.