Required Qualifications
The Packaging Engineer is responsible for the design, development, validation, implementation, and continuous improvement of packaging systems for medical devices manufactured at the site. This role ensures packaging solutions meet product protection, regulatory, quality, operational, and customer requirements while supporting FDA remediation activities, process optimization, product launches, and cost reduction initiatives. The Packaging Engineer collaborates closely with Manufacturing, Quality, R&D, Regulatory Affairs, Supply Chain, and external suppliers to deliver compliant and efficient packaging solutions.
Responsibilities include but are not limited to:
Packaging Design & Development
• Design, develop, and implement primary, secondary, and tertiary packaging systems for medical device products.
• Evaluate packaging materials, components, and configurations to ensure product protection and performance throughout the product lifecycle.
• Support new product introductions (NPI), product transfers, and packaging changes.
• Develop packaging specifications, drawings, bill of materials (BOMs), and technical documentation.
Validation & Regulatory Compliance
• Develop and execute packaging validation protocols, including:
- Installation Qualification (IQ)
-Operational Qualification (OQ)
-Performance Qualification (PQ)
• Support packaging process validation activities in compliance with:
-FDA Quality System Regulations (21 CFR Part 820)
-ISO 13485
-ISO 11607
-Good Manufacturing Practices (GMP)
• Participate in risk assessments, FMEAs, and design reviews.
• Ensure compliance with BD quality standards and documentation requirements.
Manufacturing Support
• Provide engineering support for packaging operations and manufacturing processes.
• Investigate packaging-related quality issues and implement corrective and preventive actions (CAPA).
• Lead root cause investigations using structured problem-solving methodologies.
• Support nonconformance investigations and continuous improvement initiatives.
• Partner with operations teams to improve packaging efficiency, quality, and productivity.
Continuous Improvement
• Identify and execute cost reduction and process improvement opportunities.
• Utilize Lean Manufacturing and Six Sigma tools to improve packaging performance.
• Drive initiatives related to waste reduction, material optimization, and operational excellence.
• Support digitalization and automation opportunities within packaging processes.
Cross-Functional Collaboration
• Collaborate with R&D, Product Development, Quality Assurance, Regulatory Affairs, Supply Chain, Procurement, and Manufacturing teams.
• Interface with packaging material suppliers and contract manufacturers.
• Support internal and external audits, including FDA inspections and customer audits.
• Provide technical expertise on packaging-related projects and change controls.
Education & Experience
• Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, Biomedical Engineering, or related technical field.
• 3+ years of engineering experience in packaging, manufacturing, medical device, pharmaceutical, or highly regulated industries.
• Experience with packaging validation and testing methodologies.
• Experience supporting manufacturing operations and quality systems.
• Bilingual (English/Spanish) preferred.
Technical Skills
• Packaging materials and technologies
• Packaging equipment and automation systems
• FDA regulations and GMP requirements
• Statistical analysis and validation methodologies
• Risk management and FMEA processes
• Root cause analysis and CAPA systems
• Microsoft Office Suite
• SAP, Oracle, or similar ERP systems
• Statistical software (Minitab preferred)
• CAD software preferred
Key Competencies
• Strong analytical and problem-solving skills.
• Excellent project management abilities.
• Effective verbal and written communication skills.
• Ability to influence cross-functional teams.
• Strong organizational and documentation skills.
• Results-oriented with a continuous improvement mindset.
• Ability to work in manufacturing and cleanroom environment
• Bilingual (English/Spanish) preferred.
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