Senior Packaging Engineer

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: Leads successful validations 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 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.