Title:  Senior Industrial Engineer, Manufacturing

QUALIFICATIONS

Required:

• Bachelor’s degree in Industrial, Biomedical, or related Engineering from an accredited university
• 6+ experience in a Regulated industry such as Medical Device or Pharmaceutical
• Experience with discreet manufacturing and inspection technologies (heat staking, ultrasonic welding, press assembly, adhesives, leak testing, vision systems, and robotics)
• Experience with Lean Manufacturing techniques
• Six Sigma Green Belt (or higher)

Preferred:

• 8+ years experience in a Regulated industry such as Medical Device or Pharmaceutical
• Experience in a high-volume manufacturing environment preferred, i.e., production 1M+ annual, cycle time < 3 second.
• Experience facilitating and leading Kaizen/ RIE events  

Skills & Competencies:

• Strong understanding of Lean principles and Continuous Improvement
• Diverse skills and experience in leading projects/ managing project timelines
• Knowledge of discreet manufacturing processes, manual and automated equipment
• Familiar with medical device manufacturing assembly and test methods
• Proficiency utilizing the MS Office Suite (Project, Word, Excel, PowerPoint, Visio, Outlook)
• Proficient with CAD programs (AutoCAD strongly preferred)
• Experience with spreadsheet and statistical analysis software packages (Excel and Minitab preferred)
• Familiar with medical device equipment qualification, computer system validation, and process validation requirements to meet FDA requirements 21 CFR 820, and 21 CFR 11
• Strong analytical and creative problem-solving skills
• Strong verbal communication and technical writing skills
• Ability to prioritize tasks and lead a varied workload to meet team objectives

Physical Requirements:

• Must be able to work at a desk or remain stationary for extended periods of time
• Must be able to access and navigate all areas of the facility, including clean rooms
• Ability to operate a computer and other office equipment, such as printer, telephone, etc.   

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RESPONSIBILITIES:

• Optimization of dock to stock process, material, and information flow
• Create and maintain value stream maps of all product SKU’s
• Define work elements and optimal process sequence
• Develop and implement optimal processes throughout manufacturing 
• Develop and maintain facility/ manufacturing floor layouts 
• Identify waste and lead continuous improvement activities to optimize manufacturing performance
• Develop and maintain standard work and other job aides as necessary
• Analyze, develop, and maintain productivity metrics 
• Work cross functionally to support the development of batch reports and dashboards to display automation equipment’s throughput and runtime capabilities.
• Work with Supply Chain and Operations to develop improved material flow  
• Provide project status updates to management
• Other duties and projects as assigned