Engineering II, Packaging

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 whats 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.

DESIRED MINIMUM QUALIFICATIONS

• Bachelors 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

Required Knowledge Skills and Abilities

• 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.

• Strong technical writing/documentation skills are preferred.
• Elevated level of written and verbal communications skills.
• Proficient PC skills (MS Word MS Excel MS Project MS Visio).

Travel Requirements

• Travel as needed 15% 25% (domestic and international)

Physical Requirements

• 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.

Position is located in our Columbia MD facility (hybrid - 3 days)

Salary Pay Range:

Our salary ranges are determined by role level and location. Individual pay is determined by several factors including job-related skills experience and relevant education or training. In addition to base pay employees may be eligible for bonus commission equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

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)).

Subject to the terms of their respective policies and date of hire Employees are eligible for the following 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 youd like more information on your rights under the law please see the following notices:
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Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency and it must be executed and authorized by the Vice President Talent Acquisition. Where agency agreements are in place introductions (the initial sharing of a candidates name resume or background) are position-specific and may only occur within the scope of that approved agreement. Please no phone calls or emails.

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