Process Engineer Level I

• Participates in or leads major process improvement initiatives from identification to execution
• Identifies gaps in processes, develops project plans, and cost reduction/avoidance. Monitors progress and assess adequacy of output/deliverables
• Champions the understanding and application of Lean principles and techniques to maximize yield, capacity, and capability
• Creates and maintains Manufacturing Instructions, routings, and associated processes. Ensures effective training for new or changed processes
• Manages/Executes process validation activities for IQ (installation qualification), OQ (Operational Qualification), and PQ (Performance Qualification)
• Analyzes and maintains Value Stream Maps for ongoing processes to ensure efficient factory utilization
• Participates in infrastructure optimization and expansion
• Utilizes Lean methodology (e.g., DMAIC, Lean Manufacturing, Continuous Improvement (Kaizen), PDCA, etc.) to support the design of optimal processes
• Designs and implements layout of equipment, materials, and work cells for maximum efficiency
• Analyzes factory data and recommends projects activities to improve overall factory efficiency
• Analyzes manufacturing and field defect data, and creates and implements process improvement programs.
• Deploys standard processes and communicates cross-functional needs
• Develops best practices and standardized operating instructions to optimize processes
• Evaluates processes and equipment to ensure compliance with applicable environmental, safety and quality regulations and standards
• Monitors and reduces process variation using techniques such as Statistical Process Control (SPC), Root-Cause Analysis, Data Analytics, Scripting, Database Query Development, Product Flow Optimizations and Tableau Dashboard Development
• Participates in the development and maintenance of FMEAs and Control Plans
• Eliminates human errors by utilizing Poka Yoke
• Utilizes Line balancing, cycle time and take time to ensure customer requirements are met
• Creates ROI justifications to support process improvement initiatives
• Leads Design of Experiments (DOE) on existing and upcoming processes
• Interfaces directly with assemblers, leads, and production supervisors in resolving production problems
• Identifies automation opportunities and implements solutions
• Ability to complete hands-on tasks, up to and including actual equipment production runs
• Monitors procedural and engineering change releases
• assess departmental impact
• Analyzes, develops, processes, and implements Engineering Change Orders (ECO), Manufacturer and Departmental Document change control (MCO & DCO)
• Ensures effective departmental interfaces
• facilitates interdepartmental communication
• Escalates problems and potential issues through management channels as necessary
• Additional task and duties as assigned

• Bachelor's Degree Industrial, Manufacturing, or Mechanical Engineering or related technical field with required relevant work experience
• 5+ Years Process engineering or manufacturing experience in relevant industry with educational requirement preferred
• 2+ Years Years Process engineering or manufacturing experience in relevant industry with advanced degree requirement preferred
• 1+ Years Years Experience in a GMP and FDA regulated industry and/or a ISO certified organization preferred
• Proficient in Microsoft Word, Excel, Access, Visio and PowerPoint programs (High proficiency)
• Thorough knowledge of cGMP regulations (High proficiency)
• Highly organized with proven time management and prioritization skills (High proficiency)
• Ability to work independently (High proficiency)
• Ability to handle tight deadlines, frequent assignment changes, periodic heavy workload, rapidly changing technology, and dynamic business growth (High proficiency)
• Strong statistical and data analysis skills
• knowledge of Statistical Process Control (SPC) and Design of Experiment (DOE) (High proficiency)
• Ability to use a systematic approach for Root Cause Analysis and knowledge of systems/processes to ensure data-driven decisions (High proficiency)
• Ability to handle multiple projects and lead positive change (High proficiency)
• Experience with time study methodologies and industrial engineering basics (High proficiency)
• Team player capable of working across functional groups to qualify new processes/ materials under a compressed schedule (High proficiency)
• Experience with LEAN Manufacturing and Six Sigma Problem solving Methodology (High proficiency)
• Ability to effectively solve complex technical problems (Medium proficiency)
• Develop in-depth knowledge across multiple business units and technical areas (Medium proficiency)
• Excellent interpersonal and oral and written communication skills (Medium proficiency)
• Mechanical design capabilities utilizing Solidworks is preferred (Medium proficiency)
• Lean Six Sigma Black Belt preferred
• ASQ Certified Quality Engineer preferred

• Lean Six Sigma Black Belt
• ASQ Certified Quality Engineer

competitive salary and benefits package