Packaging Engineer
$31,200–$31,200 year
On-siteConcord, North Carolina, United States
Job Summary
Design, develop, and implement primary, secondary, and tertiary packaging systems for medical devices while evaluating materials to ensure product protection throughout the lifecycle. Execute validation protocols including IQ, OQ, and PQ in compliance with FDA 21 CFR Part 820, ISO 13485, and GMP standards. Support new product introductions, product transfers, and packaging changes by developing specifications, drawings, and bill of materials. Investigate quality issues, lead root cause analyses, and implement corrective and preventive actions to drive continuous improvement using Lean Manufacturing and Six Sigma tools. Collaborate cross-functionally with Manufacturing, Quality, R&D, Regulatory Affairs, and Supply Chain to deliver compliant solutions and support FDA remediation activities.
Required Qualifications
- 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)
- 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
- Experience with packaging materials and technologies
- Experience with packaging equipment and automation systems
- Knowledge of FDA regulations and GMP requirements
- Experience with statistical analysis and validation methodologies
- Experience with risk management and FMEA processes
- Experience with root cause analysis and CAPA systems
- Experience with Microsoft Office Suite
- Experience with SAP, Oracle, or similar ERP systems
- Experience with statistical software (Minitab)
- Experience with CAD software
Desired Qualifications
- Minitab
- CAD software
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