Required Qualifications Bachelor’s degree in Packaging, Mechanical, Biomedical Engineering or a related technical field, with equivalent experience also considered; advanced degree preferred. Minimum of 3 years of experience in packaging engineering within the medical device or drug development industries. Proven track record developing different packaging design systems for sterile medical device and/or pharmaceutical products. Demonstrated understanding to ISO 11607-1 & 2, ISO 13485, ISO 16975, ICH Guidelines, and packaging-related ASTM or ISTA standards. Demonstrated expertise in Design for Six Sigma (DFSS), statistical analysis, and Design of Experiments methodologies. Proven ability to define and document packaging requirements for sterile packaging solutions. Proficient designing different packaging systems types for medical devices and pharmaceutical products. Experience with packaging design software ex. CAPE or TOPS and Solidworks. Skilled in verification and validation of content sterile packaging systems, ensuring compliance with regulatory standards. Experienced developing Packaging PFMEA and DFMEA. Proven experience developing technical rationales and design verification by analysis for pharmaceutical and/or medical device closure systems. Experience performing FEA to evaluate and optimize packaging designs. Understanding and application of core engineering principles, including first-principles analysis and calculations, to address packaging design challenges and development activities.
Packaging Engineer • Montgomery, AL, US
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