Engineer, Package

Title:

Sr Engineer, Packaging

FLSA:

Exempt

Reports to:

Manufacturing Engineering Mgr.

Level:

Z11

Job Family:

Operations

Business Unit:

Spine

Origination Date:

May 1, 2005

Revision Date:





Job Summary –

Responsible for the design of packaging configurations for sterile and non-sterile packaged products, including labeling. Support and assist with the development of manufacturing processes and documentation for new and existing products.



General Functions –

§ Develop package designs for product families assigned including the development of component and material costs. Implementation of design through manufacturing.

§ Provide support as required to contract manufacturers on packaging related issues: process validations, process improvements and day-to-day support.

§ Responsible for product label generation system, including label format development as well as daily production support.

§ Validate package designs and implementation into manufacturing, including process validation.

§ Support quality control in deciding the next course of action for product held in material review board.

§ Generate mechanisms required to implement processes and manage product flow (e.g. routers, prints, BOMs).

§ Assist with the development of tests and write test protocols and reports to document tests.

§ Identify and address corrective and preventive actions (CAPA).



This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA



Expected Areas of Competence (i.e. KSAs) –

§ Effectively manages multiple priorities with high quality expectations in a team-based environment.

§ Actively participates in development meetings with assigned development teams.

§ Ability to effectively work within a team to expedite completion of critical project tasks with other functional groups.



Education Requirements – B.S. in packaging engineering, mechanical, or industrial engineering.



Skill Requirements – Microsoft Office Suite and Project. 5-7 years experience in medical device packaging. Experience in conducting package design validations and package process validations. Materials experience: Tyvek, thermoformed trays, heat seal coatings applied to Tyvek or paper, chevron pouches. Working knowledge of US and ISO standards related to packaging and labeling; including ISO11607.



Licenses/Certifications –



Travel Requirements – Minimum overnight travel (up to 10%) land or air.



Approvals



__________________________________________________ _____________________

Manager Date



__________________________________________________ _____________________Human Resources Date Education: BachelorsJob Level: 6 - 7 yearsPercent Travel: 1-10%