Packaging Engineer

Long Term Contract Role

Note - Medical Device Domain Exp is Must.

• 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.