Process Engineer I

Process Engineer I role focuses on understanding, optimizing, and sustaining manufacturing processes using lean and six sigma methodologies. The position works cross-functionally to improve efficiency, ensure regulatory compliance, and drive quality improvements across product lifecycles.

Responsibilities

• Execute process engineering tasks and support validation activities, engineering studies, and change controls
• Conduct investigations, non-conformances, and CAPA activities as a contributing team member
• Perform statistical process control analysis and trending to improve yields and reduce scrap
• Respond to manufacturing floor escalations and coordinate with leadership and appropriate departments
• Work cross-functionally with quality, regulatory, facilities, and product development teams on process improvements

Requirements

• Bachelor's degree in Engineering or Science
• 0–3 years of relevant process engineering or manufacturing experience
• Knowledge of lean and six sigma tools and methodologies
• Familiarity with ERP systems (SAP), QMS platforms, and statistical analysis software
• Understanding of FDA regulations, GMP, ISO 9001, and ISO 13485 standards
• Ability to work in manufacturing, cleanroom, and laboratory environments

Compensation: $62,100.00 - $85,100.00 USD Salary