Senior Principal Engineer, Plastics Molding — Pharmaceutical Manufacturing & Medical Devices

Senior Principal Engineer leading enterprise-level technical strategy for plastic injection and blow molding technologies in pharmaceutical and medical device manufacturing. The role manages complex engineering projects across product and process lifecycles, ensuring robust, compliant, and scalable molding solutions through collaboration with internal teams and external suppliers.

Responsibilities

• Lead medium to large-scale molding engineering projects from concept through qualification, validation, and sustained support
• Develop injection and blow-molding solutions meeting product, process, quality, cost, and regulatory requirements
• Conduct risk assessments, manage life-cycle costs, and communicate technical recommendations to management
• Support supplier selection, performance monitoring, and technical issue resolution for molds, equipment, and automation
• Execute FMEAs, DOE, dimensional analysis, SPC, FAT, equipment qualification, and validation activities

Requirements

• Bachelor's degree in Mechanical Engineering, Plastics Engineering, or related field; equivalent technical experience considered
• 8–10 years engineering or operational experience in pharmaceutical, medical device, biologics, or regulated industry
• 3+ years plastic injection or blow molding design and process-support experience
• Demonstrated knowledge of molding equipment, resins, tooling, SPC analysis, and regulatory/ISO requirements
• Experience with FMEA, DOE, dimensional analysis, FAT, validation, design controls, metrology, and quality systems
• Proficiency with CAD platforms including SolidWorks, Creo/ProE, and AutoCAD