Production Engineer III, Manufacturing

Title

Production Engineer III, Manufacturing

Join to apply for the Production III, Manufacturing role at Enable Injections, Inc.

Onsite

Full Time

• Bachelor’s Degree in a technical discipline (e.g. Engineering or Science) and/or equivalent education/experience
• Minimum of 4 years of experience in FDA regulated manufacturing and/or process/equipment/product development
• Beginning experience leading cross-functional teams, projects, and/or direct reports
• Experience with medical device manufacturing process technologies: heat staking, ultrasonic and laser welding, press assembly, robotics, leak and flow testing, functional testing

• Experience in a high-volume FDA regulated commercial manufacturing environment
• Lean Six Sigma Green or Black Belt Certification (LSSGB/LSSBB)

• Strong attention to detail and commitment to quality
• Excellent verbal communication and technical writing skills
• Ability to troubleshoot equipment and processes using investigation techniques (5 Why’s, Fishbone Diagram, etc.)
• General knowledge and understanding of automation: vision systems, robotics, and PLCs
• Understanding and application of 21 CFR 820 Medical Device Quality System Regulation relevant to manufacturing support
• Proficient with the MS Office Suite (Word, PowerPoint, Excel, Visio)
• CAD or AutoCAD design and drafting skills
• Ability to plan and carry out sequential projects independently
• Ability to analyze problems and troubleshoot solutions effectively
• Ability to foster teamwork, collaboration, negotiation, and influencing others at the project team level
• Ability to adapt behaviors and activities during times of change and handle unexpected situations with minimal guidance
• Exemplifies flexibility and resourcefulness in responding to challenges and opportunities
• Strong time management skills and ability to manage multiple priorities
• Ability to maintain a positive attitude, show empathy for others, and act with integrity in support of company goals and a healthy work environment

• Must be able to remain in a stationary position for extended periods of time
• Ability to operate a computer and other office equipment for extended periods of time
• Ability to lift 50 lbs.
• Ability to work within, crouch, stoop, bend around and potentially underneath equipment for extended periods of time
• Position requires being physically present on the premises during regular company hours or as approved by management

• Manufacturing Support:
  Respond rapidly to downtime events and support efforts to bring production back online as quickly as possible
• Continuous Improvement:
  Identify opportunities to improve yield/throughput/labor and begin leading implementation with guidance
• Quality System Documentation:
  Author documents such as NCRs, CAPAs, change controls, and rework instructions; present at cross-functional review boards; author/revise DCOs and routers in SAP
• Root Cause Investigations:
  Support product/process/equipment investigations with cross-functional teams
• Production Model:
  Create and maintain labor/capacity/yield models for manufacturing lines
• Engineering Builds:
  Support development builds; write engineering reports to summarize builds
• Build Protocols and Reports:
  Author build protocols and reports
• Training:
  Act as approved trainer for manufacturing operators
• Layout/Workflow:
  Participate in efforts to optimize layouts and workflows using lean methodologies
• Other duties as assigned

Cincinnati