Dear Partners,
 Please find the below requirement and respond with suitable profiles
to [email protected].

Role: Packaging Engineer
Location: Santa Rosa, CA
Duration: 10 Months
Rate: Open

Job Responsibilities and Requirement:

•       Responsible for the design, development, and support of package
systems for sterile medical devices including components, assemblies,
and labels

Position Responsibilities

•       Development of packaging and labeling components, and assemblies for
sterile (sterilized by Ethylene Oxide, Steam, Gamma methods), medical
products in support of R&D / new products
•       Coordination and communication of packaging technology and designs
with project teams as part of the Product Development Process
•       Provide technical recommendations and coordinate introduction /
implement changes in the packaging process and materials.
•       Actively collaborate with Packaging and Labeling peers within
CardioVascular to identify and implement best practices, packages and
processes.
•       As requested, participate on cross-functional, cross-site project
teams focusing on packaging, technology and processes improvements
•       Know FDA and ISO requirements related to packaging and labeling, how
to conduct thorough validations
•       Experienced with IQ/OQ/PQ as part of packaging processes
•       Draft technical documentation including package testing protocols
and validation associated with the qualification and release of
package designs
•       Process development and support for packaging assemblies for 
manufacturing
•       Develop plans to establish proof shelf life (shelf life) accelerated
and real time.
•       Proficient in the use of computers, intranet/internet, PC
applications, and labeling systems
•       Manage projects and deadlines to ensure all new product and package
improvement deadlines are met
•       Serve actively in the identification of suppliers, testing and
approving materials, including liaison with the vendors.

Required Skills:

•       BS Packaging or Engineering (Mechanical or Materials)
•       Minimum of 2 years medical device packaging experience
•       Certified Packaging Professional (CPP) preferred.
•       Experience with automated and/or semi-automated packaging equipment
and processes
•       Knowledgeable in ISO, ASTM, ISTA standards related to packaging.
•       Solid proficiency in MS Word, Excel and statistical analysis
software Preferred Qualifications
•       Experience with data base driven labeling systems
•       Experience with DFLS, DFM, process development and design of
experiments (DOE) methodology



Thanks & Regards,

Lakshmi P
Talent Acquisition Executive
7950, Dublin Blvd, Suite # 309,
Dublin, CA 94568
Phone: 408-409-7521
[email protected]
www.techsophy.com

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