**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.
