Sr. Package Engineer - OQSIE

Package Engineer Consultant

This position has a New Product Development focus and will provide overall package engineering support for new
product development teams. Will prototype, design, develop and validate packaging systems to primarily support
clinical trials, limited market releases and full scale product launches.
Specifically the incumbent will provide R&D package engineering & project management support for new product
launches, clinical trials, global and limited market releases as well as key operations initiatives. Drive new packaging
technologies and strategies to improve time to market with a focus on Functional Excellence and Value Expansion to
develop world-class capabilities and provide a competitive advantage to the company .
Key activities for this position will include developing and executing protocols for package design, packaging
processes validation and package shelf life testing. Help support and drive new packaging technologies and
strategies to improve time to market and advance the technology of package engineering at the company .
Working through continuous changes resulting from a dynamic product development environment and translate the
device changes into the package development process, working closely and continuously with cross-functional team
members and outside suppliers of materials and services.
Validating packaging equipment and packaging manufacturing processes. Source, purchase, install and validate
equipment as well as develop and validate packaging processes.

Sr. Packaging Engineer requires a minimum of four years package engineering experience;
Experience in a medical device, biotechnology or a pharmaceutical environment is preferred but not required.
Experience in an FDA regulated industry, preferably medical device is optimal.
Knowledge of methods of sterilization and design requirements for medical device packaging is also preferred.
A Bachelor's degree is required, preferably in Package Engineering, but will consider a relevant scientific or
engineering degree. A Master's degree in Business Administration or Package Engineering, Engineering, or related
science/technical degree field is preferred.
The packaging engineer must demonstrate a strong working knowledge of standardized package testing, industry
standards such as ISO, ASTM, EN868, and AAMI and good working knowledge of device regulatory requirements.
Successful completion of an academic program or having past work experiences which provide a detailed technical
knowledge of performance and compatibility of common medical device packaging materials and adhesives such as
Tyvek, or HIPS, or PETG, or Polycarbonate, or Polyolefin's, or co-ex films as well a detailed knowledge of material
forming processes such as thermoforming, or injection molding, or extrusion/extrusion blow, or FFS is desired.
Ability to develop and execute protocols for package design, packaging processes validation and package shelf life
testing, validate packaging equipment and packaging manufacturing processes; source, purchase, install and validate
equipment as well as develop and validate packaging processes; support and drive new packaging technologies and
strategies to improve time to market and advance the technology of package engineering - rapid prototype design &
development