Process Engineer

Orion Industries, Ltd.; Chicago (IL); On-site; USD 90,000 - 120,000; Full time

Job summary

Orion Industries, Ltd. seeks an experienced engineer to lead design transfer to manufacturing and support process validations. You will craft IQ/OQ/PQ protocols, review processes for cost-efficiency, and identify new technologies with cross-functional teams.

You will also drive automation transitions, manage timelines, and contribute to quality and EH&S programs while mentoring operators and setup staff in a fast-paced environment.

Qualifications

• Bachelor’s degree in Mechanical Engineering or related field.
• Experience in ISO 13485 or ISO 9001 regulated environment.
• 5+ years in an engineering role, preferably in coating, metal finishing or manufacturing.
• Excel, Word, Outlook, Microsoft Project, Minitab proficiency.

Responsibilities

• Create IQ/OQ/PQ protocols and final reports for new process/equipment development.
• Assess manufacturing processes for cost effectiveness and feasibility.
• Identify new manufacturing or product technologies for review with production/engineering teams.
• Support transition from manual to automated processes.
• Maintain project timelines and detailed documentation.
• Collaborate with Production, Quality and Engineering teams.
• Train Operators/Setup Techs.
• Troubleshoot tooling, fixtures and equipment issues.
• Maintain preventive maintenance programs and track maintenance.
• Create Value Stream Maps of current and future manufacturing states.
• Facilitate 6S, Lean Six Sigma and Bright Idea programs.
• Recommends cost-saving initiatives to reduce scrap and material variance.

Skills

Project management

Presentation skills

Communication

Written communication

Interpersonal skills

Process mapping

Engineering projects

Education

Mechanical Engineering degree

Chemistry degree

Chemical Engineering degree

Materials/Polymer Science degree

Related field degree

Tools

AutoCad

Inventor

Solidworks

Job description

• Responsible for Maintaining Processes and Equipment in a Full Capacity State and Minimizing Equipment Downtime
• Responsible for Supporting Design Transfer to Manufacturing for New Process/Product Developments and supporting Process Validations projects
• Responsible for Equipment, Fixturing and Tooling design
• Responsible for maintaining and communicating project timelines to Production, Quality and Engineering Team Members
• Assists with Root Cause and Nonconformance Investigations and corrective/preventive action implementation as well as determining opportunities for improvement
• Supports the Facility EH&S and Environmental Monitoring Programs
• Interacts with other functional areas such as Production, Quality Assurance, Purchasing, Scheduling, and Customer Service.

Essential Functions

• Creates IQ/OQ/PQ protocols and final reports for new process and equipment development according to internal procedures and risk-based approaches
• Determines and reviews manufacturing processes for cost effectiveness and feasibility, both before and after engineering releases to manufacturing
• Identifies new manufacturing or product technologies for review and possible development activities within the production and engineering teams.
• Supports Transition from Manual to Automated Processes
• Determines project priorities with the Operations Managers and Engineering Director, and implements cost-reduction projects; maintains timelines and detailed documentation as required
• Creates Value Stream Maps of Current Manufacturing and Future Manufacturing States
• Assures work force utilization, facility layout and operational data, process flow charts and determine efficient utilization of workers and equipment
• Collaborates and Trains Operators/Setup Techs
• Troubleshoots Current Tooling, Fixture and Equipment Issues
• Creates Troubleshooting Guides for Equipment
• Evaluates Machine Preventive Maintenance Program and tracks Unscheduled Maintenance
• Supports Maintenance of Equipment and Robotics/Automation
• Provides Feedback to Departmental Leads and Supervisors on Maintaining Equipment Efficiencies and Standardization of Processes and Setups
• Facilitates 6S, Lean Six Sigma, and Bright Idea Programs for assigned Departments
• Maintains Troubleshooting Binder for Each Machine Containing:
  • -Wiring Diagram
  • -Equipment Drawings
  • -Troubleshooting Guides
  • -Maintenance Records
  • -Replacement Parts List

• Recommends, develops and implements cost saving initiatives (Value Improvement Projects) to reduce Scrap and Material Usage Variance (MUV).
• Reviews opportunities for improvement with facility EH&S and Environmental Monitoring Programs
• Maintains regulatory compliance associated with REACH, RoHS, SVHC, TSCA, RCRA, and Employee Hygiene Programs and local, state, and federal requirements (OSHA, EPA, City of Chicago, and ISO 9001/13485).
• Excellent Project Management, Presentation Skills, Communication and Writing skills.
• Interpersonal skills due to multiple interactions between functional areas
• Ability to organize logical process maps to meet critical design deadlines.
• Ability to structure engineering projects.
• Strong communication skills in an engineering environment between multiple engineering disciplines and departments
• OSHA, FDA 21 CFR 820, ISO 13485, ISO 14791, ISO 9001, and Local Government Regulations

Required Education and Experience

• Bachelor’s degree in Mechanical Engineering, Chemistry, Chemical Engineering, Material/Polymer Science or related fields.
• Experience working in ISO 13485 or ISO 9001 regulated environment
• 5+ years experience in engineering role, preferable within the coating, metal finishing or manufacturing
• Computer proficiency in Excel, Word, Outlook, Microsoft Project, Minitab
• AutoCad, Inventor and/or Solidworks
• Experience with the application of statistical techniques such as statistical process control, design of experiments, and problem solving.

Knowledge of Regulations

• ISO 9001/AS9100D
• ISO 13485
• 21 CFR 820
• OSHA
• EPA
• REACH, RoHS, TSCA, SVHC
• Manufacturing Environment
• PPE provided for vision, respiratory, and hearing protection when required

Physical Demands

While performing the duties of this job, the employee is occasionally required to climb or balance and stoop, kneel, crouch or crawl. Occasionally lift or move equipment.