Senior Packaging Engineer

1 week ago


Lafayette, United States Redbock - an NES Fircroft company Full time

**CANDIDATES CURRNETLY WORKING UNDER F1 OPT/F1 OPT STEM/H1-B WILL NOT BE CONSIDERED. W2 CANDIDATES ONLY**


Sr. Packaging Engineer (6 month contract // North Haven, CT or Lafayette, CO):

Hybrid, onsite 3 days per week (North Haven CT or Lafayette CO)

Top 3 Required Skills:

  1. Leads successful validations of packaging systems for medical devices
  2. Able to conduct Packaging systems Gap Analysis according to ISO11607 Part 1 and 2
  3. Lead project meetings and provide updates to management


Description:

The packaging engineer is part of a dynamic team that provides expertise in packaging engineering and ensures quality and regulatory compliance. Supports and/or leads projects and collaborates with stakeholders to achieve desired results.


Duties:

  • Evaluate the current state of various medical device product packaging design; perform gap analysis on existing studies to the latest industry standards such as ISO11607 Part 1 and 2.
  • Generate and execute packaging remediation plans for sterile barrier systems and non-sterile medical device packaging. Define remediation plans, generate/execute protocols, author closing reports, update specifications and technical documentation.
  • Leads successful validation of packaging systems for medical devices
  • Identify and develop innovative packaging processes and designs as part of a cross functional team. Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of device protection required.
  • Utilize quality and regulatory compliance knowledge to support regulatory body audits, draft technical responses and provide innovative ideas to ensure compliance to latest industry practices.
  • Lead project meetings and provide updates to management.
  • Assist in labeling development process.
  • May perform and evaluate testing in a laboratory environment as per industry standards.


Minimum Requirements:

  • Bachelor of Science Degree in Packaging Science, Mechanical Engineering or similar discipline.
  • Minimum of 5 years in medical device or pharmaceutical industry in Packaging or Quality Engineering.
  • Requires practical knowledge and demonstrated competence within packaging engineering typically obtained through advanced education combined with experience.
  • Knowledge and general understanding of ISO 11607 part 1 and 2, ASTM and ISTA package test methods is required.
  • Established and productive individual contributor with strong team and interpersonal skills.
  • Knowledge of Microsoft Office programs is required.
  • CAD/CAPE/TOPS Software knowledge is preferred.

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