| Location | Lafayette |
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:
• Evaluatethe 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.
Requirement:
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.
Top 3 technical skills that are required for the role:
1.Leads successful validations of packaging systems for medical devices
2.Able to conduct Packaging systems Gap Analysis according to ISO11607 Part 1 and 2
3.Lead project meetings and provide updates to management
Education Required: Bachelor of Science Degree in Packaging Science, Mechanical Engineering or similar discipline
Years' Experience Required: Minimum of 5 years in medical device or pharmaceutical industry in Packaging
Benefits:
Benefits
Full-time employees (working an average of 30 hours or more) are eligible to select from different benefits packages Packages may include medical, dental, and vision benefits, a 401(k) retirement savings plan with employer match (available after 1 year of employment), commuter benefits, employee discount and referral programs, and life and supplemental income insurance Paid sick leave is provided in accordance with applicable state and local laws.
Compensation
Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education, and experience, as well as the benefits package you select.
Work Authorization
ATR International, Inc cannot sponsor work visas (H-1B, F-1 STEM OPT with I-983, or similar) Candidates must have valid U.S work authorization.
ATR International, Inc is an equal opportunity employer We celebrate diversity and are committed to creating an inclusive environment for all employees.