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The Packaging Engineer Manager is responsible for managing all aspects of the design, development, and validation of packages and packaging systems for medical devices at Tissue Technologies division of Integra, in compliance with applicable FDA and ISO requirements.

This individual is responsible for providing departmental technical expertise for package development while collaborating with regulatory, marketing, market research, supply chain, process excellence and other affiliated departments and organizations to identify and address packaging needs.

These duties include managing the strategy for the development of sterile barrier systems and secondary packaging, creating, and maintaining detailed specifications, creating, and executing validation/qualification protocols, and responsibility for packaging equipment selection and development, material selection, supplier selection, and labeling.

• Manage the design, development, and qualification of packages and packaging systems for sterile and non-sterile medical devices at Integra Lifesciences.

• Articulate and drive packaging strategy and develop the associated Standard Operating Procedures (SOPs) and best practices to ensure success and align to current regulations and business strategies

• Establish timelines, budget estimates, and resource requirements for package development, sustaining and continuous improvement projects and drive the projects to successful completion

• Mentor the Tissue Technologies R&D Packaging Engineering team members and provide project direction, prioritization, and technical oversight to ensure successful implementation of packaging strategy in support of product leadership goals.

• Support the conceptualization, initiation, development and implementation of new packages and processes including design generation, prototyping, consumer acceptance testing, engineering specifications, verification and validation, and technology transfer

• Identify and investigate industry best practices and implementation improvements as appropriate

• Demonstrate technical expertise on packaging, materials, and processes along with the ability to communicate that knowledge to internal and external partners

• Prepare and maintaining the departmental policies, procedures, and manuals

• Investigate design changes and failures, product complaints, and non-conformances, report findings and recommendations in company systems for corrective and preventive action

• Prepare Failure Mode Effects Analysis (FMEA) and risk assessments for products and processes

• Process validations of new and modified designs and processes

• Collaborate with Quality to ensure compliance to appropriate ISO/FDA regulations for the design, testing, documentation, and manufacturing of the company’s products

• Interface with Manufacturing, Quality, Regulatory, Research & Development, Sales, Marketing, and outside vendors to accomplish assigned tasks

• Perform other duties as assigned

• Demonstrate a commitment to understanding packaging and labeling related global medical device manufacturing, ISO 13485, and regulations through active participation in company training as well as through self-education by reading related articles and attending seminars

• Work effectively on computers using Microsoft Office and Minitab statistical software to collect data, create histograms and graphs, and write protocols and reports

Qualifications:

• Minimum of a bachelor’s degree in Packaging Engineering or other engineering disciplines or possess the equivalent combination of education and experience. A master’s degree in Packaging Engineering or other engineering disciplines is preferred.

• Minimum of 10 years of experience developing and validating packaging systems for medical devices.

• Expert knowledge of the U.S. and International standards governing the design, development, testing, and manufacture of medical devices, particularly ISO 11607, ISO 13485 well as ASTM and ISTA test methods and practices.

• Expert knowledge of U.S. FDA, cGMP, and ISO requirements for the design, validation, manufacturing processes, secondary operations, and assembly of packaging systems

• Manager direct reports through profess

• Ability to drive projects with tight timelines and drive them to successful completion.

• Excellent verbal and written communication skills; ability to lead meetings and effectively present to a group

• Demonstrate effective time management and verbal and written communication.

• Critical thinking and problem solving to develop solutions

• Knowledge of gamma, ETO, and e-beam sterilization methods

• Proficient is computer software programs such as SolidWorks, ArtisoCAD, and barcode generation software (Bartender, Loftware, Labelview.).

• Proficient PC skills (MS Word, MS Excel, MS Project, MS Visio).

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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