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Packaging Engineer

1 month ago

Grand Rapids, United States Novozen Healthcare LLC Full time

Senior Design Packaging Engineer - Grand Rapids, MI

Overview: A leading medical device company is seeking a Sr. Design Packaging Engineer to join their Packaging and Labeling team for a yearlong contract in Grand Rapids, MI. This individual will play a pivotal role in various sustaining packaging engineering projects, focusing on quality, cost savings, and service.

Key Responsibilities:

  • Lead and support packaging engineering projects for both sterile barrier systems and non-sterile medical device packaging.
  • Develop and execute packaging remediation and qualification plans.
  • Define qualification plans, author and execute Design Verification (DV), aging protocols, testing, and closing reports.
  • Utilize knowledge of quality and regulatory compliance to support regulatory body audits, Corrective and Preventive Actions (CAPA), and Nonconformance Material Reports (NCMR).
  • Provide innovative solutions to ensure compliance with the latest industry practices.
  • Conduct gap analysis on existing packaging designs against current industry standards such as ISO 11607 Part 1 and 2.
  • Determine packaging specifications based on product nature, cost constraints, legal requirements, and required device protection.
  • Update packaging material specifications and technical documentation.

Required Skills & Experience:

  • Minimum of 3-5 years in packaging engineering within the medical device or pharmaceutical industry.
  • Practical knowledge and demonstrated competence in packaging engineering, typically obtained through advanced education and experience.
  • Understanding of ISO 11607 Part 1 and 2.
  • Bachelor’s degree in Packaging Science, Mechanical Engineering, or a related discipline.

Preferred Skills & Experience:

  • Experience with Form-Fill-Seal (FFS) equipment.
  • Experience with CAPA and NCMR processes.
  • Advanced education or degree in a related field.

Additional Information:

  • The ideal candidate will have a strong background in the medical device or pharmaceutical industry.
  • Must be comfortable working onsite in Grand Rapids, MI, three days a week.