Staff Packaging Engineer - Columbia MD

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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 whats 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 (onsite) this successful individual will take an individual contributor staff level role with packaging projects and possess the ability to influence multifunctional 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 nonsterile 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 crossfunctional 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 bachelors degree in Packaging Engineering or a related Science field.
• A minimum of 8 years of experience. A Masters 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.

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