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PACKAGING ENGINEER 3

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  • ID: 496107
  • Posted: 11/17/2021
  • Location: Sunnyvale, CA
  • Category: Pro - Professional
  • Job Type: Temporary
  • Duration: 9 - 12 Months

Description

Acara Solutions is looking for a Packaging Engineer for our Client located in Sunnyvale, CA.

  • As part of the Packaging Engineering team, the person in this position will work to design and qualify packaging systems for instruments, accessories, endoscopes and system FRU's across all ISI business units.
  • The work will include designing, validating, and verifying packaging systems that include but not limited to, thermoform packaging such as Form, Fill & Seal trays, rigid trays or pouch sterile barrier systems, custom cartons, shippers, over shippers, reusable cases as well as identifying appropriate label stock for all products.
  • Design and develop best in class packaging solutions from early concept through commercialization for sterile and non-sterile medical devices (includes Field Replaceable Units - FRU's).
  • Support packaging needs from concept through end of life.
  • Design packaging solutions that meet both internal and external customer needs.
  • Own of all aspects of design verification of the packaging systems to meet design requirements and release to production.
  • Collaborate with manufacturing and process engineering to implement packaging designs compatible with class 100K clean-room environment.
  • Identify new packaging processes to improve efficiencies and reduce cost.
  • Develop component specifications, inspection plans and packaging protocols/reports to ensure that the packaging system performs to requirements.
  • Create and manage change requests within the document control system.
  • Support qualification of sealing/packaging processes within clean room.
  • Manage all projects to ensure that all internal and external packaging compliance requirements have been met and are not on the critical path for product launch.
  • Set standards within the organization on what packaging requirements are needed for ISI products.
  • As packaging SME, support audits, non-conformances and CAPAs as needed.

 

Pay and Benefits:

The salary for this position is $53.00 per hour (Max Pay rate).

 
Job Requirements

 
Required Skills / Qualifications:
  • BS degree in Packaging Engineering or Mechanical Engineering or Industrial Engineering
  • Minimum of 5 years' experience in medical device packaging design development and various packaging processes (high volume).
Preferred Skills / Qualifications:
  • Thorough working knowledge of packaging dynamics, various packaging materials and their compatibility with sterilization processes such as, but not limited to EtO, and Gamma.
  • Knowledge of packaging validation and verification requirements under CFR Part 820, ISO11607 part 1 & 2 and applicable ASTM standards. Strong understanding of GMP.
  • Design and project management skills and to manage multiple re-usable or single use disposable (SUD) packaging projects across multiple product lines, on time.
  • Strong verbal and written communication skills required to successfully collaborate with cross-functional teams and effectively communicate at multiple levels in the organization.
  • High level of service while managing a high and varied workload from internal clients and adhering to tight timelines.
  • Self-motivated with an ability to prioritize and multitask effectively in a fast-paced, dynamic environment.
  • CAD knowledge and experience (Pro-E or Solidworks).
  • Travel occasionally to vendors, subcontractors and ISI Mexico plant

Additional Information:

  • Upon offer of employment, the individual will be subject to a background check and a drug screen.


Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct, and Aleron's strategic partner, SDI) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.

Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.
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