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SUMMARY

The Staff Packaging Engineer will work within the lntegra Lifesciences CSS Engineering organization to support the packaging requirements of new and existing products. This position will provide technical expertise in the areas of medical device packaging design & development and process development & validation for new packaging equipment.

RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Works with Engineering and Manufacturing product teams as SME to develop and implement new device packages, to improve existing package designs, and to develop and improve packaging-related manufacturing processes in the CSS Manufacturing plants and at supplier locations.

• Works in compliance with GMP work practices, ISO 13485 and ISO 11607 Standards

• Participates as the team member responsible for packaging on New Product Development projects and major packaging development projects.

• Provides expertise for all elements of packaging design, testing, validation & processing.

• Leads and/or participates in risk assessments and cost improvement initiatives.

• Partners with Manufacturing, Quality, R&D, and Procurement to develop and improve packaging designs that are compliant to all containment and shipping needs of medical devices.

• Manages packaging projects with a significant scope that could involve several product codes, multiple packaging materials and processes, and manufacturing locations in both US and EU

• Demonstrates ability to develop, track, and maintain project timelines and budgets.

• Participate in projects that involve cross-functional teams as the owner of all packaging related deliverables.

• Demonstrate initiative to lead and/or participate in process improvement and task teams as needed at company and franchise levels.

• Travel as needed to domestic and international vendor sites and company locations

• Other duties as assigned

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• Demonstrated expertise in packaging technologies and their application in the medical device field.

• A thorough knowledge of medical device design control process.

• Ability to communicate effectively with colleagues, teams, management and external partners.

• Ability to collaborate with and mentor technical staff in packaging engineering discipline.

• Ability to serve as project leader for packaging related projects

Education

• Bachelors of Science in Engineering required.

• Masters of Science in Engineering preferred in Packaging Engineering

Experience

• Minimum 12 years of experience with BS or 10 years with MS in medical device packaging engineering

• Medical device industry product design and validation process knowledge of sterile packaging material characteristics and validation practices.

• Experience in writing and executing design, equipment, and process validations.

• Working knowledge of ISO 13485 Design Control and ISO 11607 Standards with application to medical devices.

• Experience In supplier selection/management for medical device packaging components and equipment.

• Statistical analysis knowledge required, Six Sigma certification preferred, experience working in integrated cross-functional product development teams.

• Excellent verbal, written and presentation skills.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.

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