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Packaging Engineer I - Medical Devices

Date Posted: 12/17/2018

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Job Description

Position Overview:

Expected to drive and manage multiple projects for supporting the needs for sustaining packaging engineering of the manufacturing sites, and developing and improving packaging solutions to Edwards's packaging operation. The position plays a key role in working with various project teams to ensure compliance, sustain product life cycle, transfer new product development to production and generate packaging cost saving and/or value added engineering projects.

 

Packaging Engineer I Duties: 
-       Apply knowledge of packaging materials, manufacturing methodologies, and the distribution environment hazards to sustain and develop sterile barrier packaging solutions that meet medical device design requirements for ISO11607 -1,2.to our product portfolio additions.

-       Develop and implement productivity and cost improvement initiatives, as part of packaging operations

-       Improvement programs and initiatives.

-       Manage packaging design projects from concept through implementation.

-       Apply a structured approach to problem solving and optimization using tools such as DMAIC, DOE, etc.

-       Develop, execute, and document Design Verification test protocols against design requirements using risk based sampling plans including package shelf life studies.

-       Draft and execute statistically based Installation, Operation, and Performance Qualifications on packaging equipment for globally based manufacturing operations.

-       Provide guidance, subject matter expertise, and oversight for packaging efforts in multiple manufacturing facilities, including Irvine, Draper, Singapore and Costa Rica.

Interface with R&D, manufacturing, clinical affairs, quality and regulatory personnel to ensure compliance with internal and external policies and procedures, Edwards Quality System Requirements, and FDA and MDD regulations



Packaging Engineer I Requirements: 

-       Must have related packaging experience.

-       Requires a Bachelor's degree in Packaging

-       Must be able to work with limited supervision, think critically, and make calculated decisions based on sound risk based analysis and business needs.

-       Strong understanding of engineering fundamentals, and a demonstrated ability to deconstruct real world issues into root engineering causes.

-       Strong communication skills are essential.

-       Must demonstrate a strong working knowledge of standardized package testing and good working knowledge of device regulatory requirements.

 

We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Job Requirements

- Requires a Bachelor's degree in Packaging

- Must be able to work with limited supervision, think critically, and make calculated decisions based on sound risk based analysis and business needs.

- Strong understanding of engineering fundamentals, and a demonstrated ability to deconstruct real world issues into root engineering causes.

- Strong communication skills are essential.

- Must demonstrate a strong working knowledge of standardized package testing and good working knowledge of device regulatory requirements.
Posted By: dmills@ultimatestaffing.com

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Job Snapshot

  • Employee Type:Full-Time
  • Location:Irvine, CA
  • Job Type:Biotech, Engineering
  • Experience:Not Specified
  • Education:Not Specified
  • Date Posted:12/17/2018
  • Contact: Denise Mills (949) 250-3511
  • Pay Range: $0.00 - $0.00 Annually
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Job Reference: JO-1812-46343