Engineering II, Packaging

Integra LifeSciences • Columbia, MD

21h • Hybrid

About The Position

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 a Manager of Packaging Engineering for Tissue Technologies, this successful individual will take an individual contributor role with packaging projects and possess the ability to influence with multi-functional, high performing teams in a fast-paced environment. This individual will be responsible for specifications, documentation, and package testing in support of New Production Introduction (NPI), Sustaining, and Continuous Improvement projects. 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. Establishes design requirements, performance, and business criteria through collaboration with health care providers, internal cross functional groups, program management and packaging team members. Work as the lead packaging 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. Proven independent technical team member. This includes but is not limited to knowledge of project management skills, ability to coordinate with cross-functional teams, technical knowledge of various medical grade material and suppliers, use of design and manufacturing methodologies, risk analysis, testing method development, and package system validation. TOOLING AND EQUIPMENT: Shall assist in developing packaging concepts using internal and external resources. Understanding of ergonomics as related to repetitive stress injuries. Define and track project tooling and equipment schedule and cost. 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, Process Characterization, IQ, OQ, and PQ for packaging equipment. Complete data analysis, identify root causes, draw conclusions, and generate reports that present sound data driven conclusions. Perform other duties as assigned.

Requirements

• Bachelor’s degree in Packaging Engineering or a related Science field, advanced degree is preferred.
• 3-5 years of experience, an M.S. degree with 2 years of experience; a Ph.D. with 1 years of experience or comparable in-depth knowledge of materials and processes used in construction and manufacturing of medical device packaging (thermoform tray, pouches, operation of sealing equipment, etc.) is required.
• Authorized to work in the United States
• Solid understanding of a broad spectrum of packaging materials, structures, components, and related conversion processes is required.
• 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 Parts 1 and 2, ISO 13487, ISO 14971, FDA 21 CFR part 820.
• Generate detailed specifications using GD&T methodologies.
• Ability to prioritize multiple rapidly changing priorities with minimal direction is required.
• General knowledge of statistical analysis i.e., DOE, ANOVA, Capability Analysis, Histograms, Normality Test.
• Elevated level of written and verbal communications skills.
• Proficient PC skills (MS Word, MS Excel, MS Project, MS Visio).
• Ability to sit for extended periods
• Ability to work on computer for extended periods
• Ability to lift and carry 50 lbs.
• Ability to work in a mechanical laboratory environment, including meeting OSHA and cGLP requirements.

Nice To Haves

• Strong technical writing/documentation skills are preferred.

Responsibilities

• 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.
• Establishes design requirements, performance, and business criteria through collaboration with health care providers, internal cross functional groups, program management and packaging team members.
• Work as the lead packaging 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.
• Shall assist in developing packaging concepts using internal and external resources.
• Define and track project tooling and equipment schedule and cost.
• 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, Process Characterization, IQ, OQ, and PQ for packaging equipment.
• Complete data analysis, identify root causes, draw conclusions, and generate reports that present sound data driven conclusions.
• Perform other duties as assigned.

Benefits

• Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level