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. Reporting to the Sr. Manager of Packaging Engineering for Tissue Technologies in Columbia, MD (on-site), this successful individual will take an individual contributor staff level role with packaging projects and possess the ability to influence multi-functional, high performing teams. This individual will be responsible for specifications, documentation, process development 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 and non-sterile medical devices 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, regulatory, sustainability and business and program objectives. + Lead strategic initiatives within the packaging team with focus on best practices, stake holder value, quality, and cost effectiveness. + Provide technical oversight to Packaging Engineers assigned to product development and lifecycle management projects. + Serve as packaging engineering representative on cross functional teams for NPI, sustaining, transfer, and other projects as necessary by collaborating with R&D, Quality, Regulatory, Labeling, Operations, suppliers, and others, to design, develop, validate, and implement package systems throughout the entire product lifecycle. + Apply knowledge of different medical device packaging testing standards in order to properly challenge a packaging system. + Demonstrate and utilize extensive knowledge of packaging engineering principles and techniques as a proven independent technical team member. This includes, but is not limited to, project management, coordination with cross-functional teams, material and supplier selection, use of design and manufacturing methodologies, risk analysis and mitigation plans, testing method development, and package system validation. + Independently determine and develop approach to solutions and present results to peers and leadership. + Support various manufacturing sites with packaging equipment process development and qualification (IQ/OQ/PQ). QUALITY: + Serve as CAPA owner to drive the investigation, develop path forward mitigation and remediation, and drive closure of the related activities. + Responsible for proper installation of new equipment and preventative maintenance plans. TOOLING AND EQUIPMENT: + Shall assist in developing packaging concepts using internal and external resources. + Responsible for proper installation of new equipment and preventative maintenance plans. VERIFICATION AND VALIDATION: + Expertise in generating test plans, writing protocols, conducting design verification/validation, and process validation for medical device packaging is required. + Executes package testing and maintains ownership of all 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 various types of packaging equipment. + Conduct analysis of 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. + A minimum of 8 years of experience. A Master's degree or other advantage degree is a plus. + In depth knowledge of materials and processes used in construction and manufacturing of medical device packaging (thermoformed trays, pouches, operation of sealing equipment, etc.) is required. + Previous experience in medical device or a healthcare discipline is required. + Solid understanding of a broad spectrum of packaging materials, structures, components, and related conversion processes is required. + Direct, 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, and EUMDR. + Ability to own CAPAs by driving the investigation, act as SME for Health Hazard Evaluations for packaging related issues, and present at the Product Safety Review Board. + Generate detail specifications using GD&T methodologies + Technical Leadership skills are required; Project Management skills are required including managing deliverables/ multiple projects/ timelines. + Strong technical writing/documentation, presentation, communication and analytical skills. Strong attention to detail along with strong critical thinking skills. + Experienced in computer software programs such as SolidWorks, ArtiosCAD, including assembly drawings is required. + Proficient in barcode generation software is preferred (Loftware, Labelview, etc.). + Proficient PC skills (MS Word, MS Excel, MS Project, MS Visio, Minitab). + **Candidate must be local to Columbia, MD or open to relocating** Travel Requirement + Travel as needed 15% - 25% (primarily domestic and potential international) Physical Requirements + Ability to sit for extended periods of time + Ability to work on computer for extended periods of time + Ability to work within packaging laboratory environment + Ability to lift, up to 50 lbs. + Typical Office Environmental Conditions + Typical Physical Laboratory Environmental Conditions 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. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada\_veterans\_employers.cfm) 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 (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . 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. Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)