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Senior Packaging Development Engineer Katalyst Healthcares & Life Sciences - 4.0 North Haven, CT Job Details Contract 1 day ago Qualifications ISO standards Gap analysis Bachelor's degree in engineering Meeting facilitation Biomedical regulatory compliance Managing projects Systems analysis Validation design

Full Job 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 & R esponsibilities: 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