Sr Packaging Engineer - W2 -Medical Device

Job Title - Sr Packaging Engineer

Job Location -, North Haven, Connecticut.

Job Description -

Hybrid 3 days in either North Haven CT office or could be located and work 3 days in Lafayette CO office.

Top 3 technical skills that are required for the role:

Leads successful validation of packaging systems for medical devices

Able to conduct Packaging systems Gap Analysis according to ISO11607 Part 1 and 2

Lead project meetings and provide updates to management

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. Responsibilities include the following:

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.