Sign upLog in
See more jobs

Senior Packaging Development Engineer

Karwell Technologies

  • North Haven, CT
  • 30+ days ago

    Highlights

    Packaging Engineer provides technical leadership for packaging development and validation, ensuring products meet quality and regulatory requirements while driving process improvements and supporting cross-functional initiatives. 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.

    Numbers & Facts

    LocationNorth Haven, CT

    Description

    Summary:
    The Sr. Packaging Engineer provides technical leadership for packaging development and validation, ensuring products meet quality and regulatory requirements while driving process improvements and supporting cross-functional initiatives.

    Roles & Responsibilities:
    • 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.
    Education & Experience:
    • Bachelor's degree in engineering
    • 5+ years of medical device or pharma packaging experience
    • Validation of Packaging Systems
    • Gap Analysis
    • ISO11607
    • Ability to conduct Packaging systems Gap Analysis according to ISO11607 Part 1
    • Experience leading project meetings

    Similar Jobs