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Responsibilities:

Reporting to the Sr. Manager of Packaging Engineering for Tissue Technologies in Columbia. MD (hybrid), this successful individual will take an individual contributor staff level role with packaging projects and possess the ability to influence with multi-functional, high performing teams. This individual will be responsible for specifications, documentation, and package testing in support of New Production Introduction (NPI), Sustaining, and Continuous Improvement projects.

ESSENTIAL FUNCTIONS OF THE POSITION:

Team member of projects involving design and manufacturing resources, both internal and external. Specific expectations include:

PACKAGING DEVELOPMENT

• Responsible for the planning, design, development, validation, and improvement of package systems for sterile medical device with a focus towards innovation, sustainability and usability that align with team and company objectives.

• Responsible for ensuring medical device packaging meets or exceeds requirements for end user functionality, safety, manufacturability, sustainability and business and program objectives

• Work as the lead engineer by collaborating with R&D, Quality, Regulatory, Labeling, Operations, suppliers, and others, to design, develop, validate, and implement package systems from exploratory through product commercialization.

• Leads strategic initiatives within the packaging team with focus on best practices, stake holder value, quality, and cost effectiveness, standard work, and design and technical rigor

• Proven independent technical team leader, including project management, coordination with cross-functional teams, and supporting more junior packaging engineers and technicians in material and supplier selection, use of design and manufacturing methodologies, risk analysis and mitigation plans, testing method development, and package system validation, plus project oversight as needed.

TOOLING AND EQUIPMENT:

• Shall assist in developing packaging concepts using internal and external resources.

• Define and track project tooling and equipment schedule and cost.

• Responsible for proper installation of new equipment and preventative maintenance plans.

VERIFICATION AND VALIDATION:

• Experience in generating test plans, writing protocols, conducting design verification/validation, and processing validation for package testing is required.

• Executes package testing and maintains complete records of packaging process and equipment design activities, test data, and other pertinent information for each project

• Able to define statistical sample sizes as related to variable and attribute data, based on established company and industry standards.

• Responsible for developing detailed process qualification strategies, IQ, OQ & PQ for equipment.

• Complete analyze data, identify root causes, draw conclusions, and generate reports that present sound data driven conclusions

QUALIFICATIONS

• A Bachelor's degree in Packaging Engineering or a related Science field, advanced degree is preferred.

• A minimum 8 years of experience, a M.S. degree with min 5 years of experience; a Ph.D. with 2 year of experience or comparable. Indepth knowledge of materials and processes used in construction and manufacturing of medical device packaging (thermoformed trays, pouches, operation of sealing equipment, etc.) is required.

• Solid understanding of a broad spectrum of packaging materials, structures, components, and related conversion processes is required.

• Extensive knowledge of FDA, ISO, ASTM, and ISTA requirements related to packaging and labeling, and how to apply them is required. Standards include, at minimum, ISO 11607, ISO 13487, FDA 21 CFR part 820.

• Generate detail specifications using GD&T methodologies

• Technical Leadership skills are required; Project Management skills are required

• Strong technical writing/documentation skills are preferred

• High level of verbal communications skills

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

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

Travel Requirement

• Travel as needed 15% – 25% (primarily domestic and some potential international)

Physical Requirements

• Ability to sit for long periods

• Ability to work on computer for long periods

• Ability to work within packaging laboratory environment

• Ability to lift up to 50lbs

Environmental Conditions

• Office area

• Moderate noise level when working in laboratory areas

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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