Senior Process Engineer, Manufacturing

1 month ago

Cincinnati, United States Enable Injections Inc Full time
QUALIFICATIONS

Required:
  • Bachelor's Degree in a technical discipline (e.g. Engineering or Science) and/or education/experience equivalent
  • A minimum of 6 years of experience in FDA regulated manufacturing and/or process/equipment/product development.
  • Strong 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
Preferred:
  • Lean Six Sigma Green or Black Belt Certification (LSSBB/GB)
Skills & Competencies:
  • Ability to troubleshoot equipment and processes. Utilize investigation techniques (5 Why's, Fishbone Diagram, etc.)
  • Strong knowledge and understanding of automation: vision systems, robotics, and Programmable Logic Controllers
  • Strong understanding of application of statistical techniques for evaluation of process and equipment performance
  • Strong 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 design and drafting (Solidworks preferred)
  • Strong influencing and negotiating skills (for lead/sr role)
  • Excellent verbal communication and technical writing skills
  • Attention to detail
Physical Requirements:
  • Must be able to stand 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.
RESPONSIBILITIES:
  • Manufacturing Support: Respond rapidly to downtime events and determine the course of action to bring production back online as quickly as possible.
  • Continuous Improvement: Identify opportunities to improve yield/throughput/labor. Lead the effort to implement the improvement.
  • Quality System documentation:Authorquality system documents such asnonconformance reports (NCR), corrective and preventive action plans (CAPA), change controls (CC), sort/rework instructions. Present documents at cross functional review boards. Author/revise procedures via document change orders (DCO).Author/revise routers as documents or data in SAP.
  • Root Cause Investigations: Lead product/process/equipmentroot cause investigations with the support of a cross functional team. Determine scrap root cause based on product/process knowledge.
  • Production Model: Create and maintain the labor/capacity/yield production model for manufacturing lines.
  • Engineering Builds: Leadequipment/process development engineering builds and tests. Write protocols and engineering reports to summarize activity
  • Training: Act as approved trainer for the manufacturing operators
  • Layout/Workflow: Determine and lead efforts to optimize layouts and workflows using lean methodologies.
  • Other duties as assigned.

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