The Packaging Engineer is responsible for the design, development, and lifecycle management of packaging and labeling systems for medical devices at BioHorizons, ensuring compliance with corporate procedures, FDA 21 CFR Part 820, EU MDR, and applicable international standards. This role leads packaging development from concept through commercialization, including material selection, design specifications, and manufacturing integration. The Packaging Engineer defines and executes verification and validation strategies to ensure packaging performance, sterility assurance, and distribution robustness.
Additionally, this role is responsible for the development and control of device labeling, including packaging graphics, Instructions for Use, and UDI/barcode implementation, ensuring global regulatory compliance and alignment with product requirements. The position operates cross-functionally to support design transfer, supplier engagement, and continuous improvement of packaging systems throughout the product lifecycle.
Essential Duties and Responsibilities:
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Contribute to packaging and labeling activities in alignment with U.S. FDA, EU MDR, and other applicable global regulatory requirements.
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Develop packaging concepts and solutions based on product design inputs, user needs, and manufacturing requirements.
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Create and maintain packaging and labeling specifications, and support prototype development, design verification, and validation activities.
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Develop and maintain technical documentation including packaging drawings, manufacturing routers, and bills of materials.
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Develop and maintain market-specific labeling content, including labels, packaging graphics, and Instructions for Use, in accordance with applicable regulatory and business requirements.
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Support the qualification of packaging and labeling equipment and software through participation in installation, operational, and performance qualification activities (IQ, OQ and PQ).
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Contributes to the development and optimization of in-house and outsourced packaging and labeling processes to improve efficiency, consistency, and scalability.
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Develop and maintain procedures and work instructions related to packaging, labeling, and production support activities.
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Evaluate packaging technologies, materials, and industry trends to support continuous improvement and innovation.
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Support risk management activities for packaging and labeling systems, including participation in documentation such as failure mode and effects analyses.
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Collaborate with production teams, automation engineers, and cross-functional stakeholders to support implementation and ongoing improvement of packaging and labeling solutions.
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Partner with Manufacturing, Quality Assurance, Regulatory Affairs, Brand Management, Operations, and external suppliers to execute assigned projects and support product lifecycle needs.
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Complete assessments of state-of-the-art standards and guidance documents related to packaging and labeling, including recommendations for due diligence.
Qualifications:
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High proficiency in MS Office Suite required.
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High proficiency in device labeling software required.
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Proficiency in CAD design software (e.g. SolidWorks) required.
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Experience with U.S. FDA, EU MDR and ISO requirements for design controls of medical devices required.
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Demonstrated ability to engage effectively and professionally with internal stakeholders and external customers across all levels of the organization
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Overnight travel may be necessary.
Education and Experience:
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Bachelor's degree in Engineering required (Mechanical or BioMedical Engineering preferred)
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Four to eight (4 - 8) years of experience working as a Medical Device Engineer (Packaging and/or Manufacturing preferred).
Benefits:
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2 comprehensive medical plan options to choose from available the first of each month following your date of hire
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Flexible Spending Account or HSA Account available
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Vision Benefits
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Company paid Dental Insurance for employee and dependents
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Wellness Plan
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401k with 5% matching
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Generous PTO plan including 11 paid holidays, 2 Floating Holidays and Community Service Hours
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Company paid Short Term Disability
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Long Term Disability
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Company provided Life Insurance
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Paid Parental Leave
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Casual Dress Code
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Social events for employees and family
Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.
Please note that any offer of employment made by BioHorizons is contingent upon the successful completion of a pre-employment background investigation to include a pre-employment drug screen
