Principal Packaging Engineer

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Principal Packaging Engineer will work within the lntegra Lifesciences Tissue Technologies R&D 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.

Reports to the Director of Packaging Development

None expected

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

Primary responsibilities are to:

• 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 Integra Life Sciences 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

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

• Bachelors of Science in Engineering required.
• Masters of Science in Engineering preferred in Packaging Engineering

• 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.

Virtual and/or on‑site office environment. Must be computer literate and familiar with Microsoft Suite of products including Project, Word, Excel, PowerPoint, Outlook, Visio and other similar applications.

The physical requirements…