Manufacturing Process Optimization Lead

3 weeks ago


Cincinnati, Ohio, United States Enable Injections Inc Full time

Job Description:

Enable Injections Inc is seeking a highly skilled Senior Process Engineer to join our team. As a key member of our manufacturing department, you will be responsible for driving process improvements, leading cross-functional teams, and ensuring the highest quality standards in our commercial manufacturing environment.

Responsibilities:

  • Manufacturing Support: Respond rapidly to downtime events, determine the course of action to bring production back online, and implement corrective actions.
  • Continuous Improvement: Identify opportunities to improve yield, throughput, and labor efficiency, and lead the effort to implement these improvements.
  • Quality System Documentation: Author quality system documents, such as nonconformance reports, CAPA plans, change controls, and sort/rework instructions, and present them at cross-functional review boards.
  • Root Cause Investigations: Lead product/process/equipment root cause investigations with a cross-functional team and determine scrap root causes based on product/process knowledge.
  • Production Model: Create and maintain the labor/capacity/yield production model for manufacturing lines.
  • Engineering Builds: Lead equipment/process development engineering builds and tests, write protocols, and summarize activity in engineering reports.
  • Training: Act as an approved trainer for manufacturing operators.
  • Layout/Workflow: Determine and lead efforts to optimize layouts and workflows using lean methodologies.
  • Other duties as assigned.

Requirements:

  • 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 Qualifications:

  • Lean Six Sigma Green or Black Belt Certification (LSSBB/GB).

Estimated Salary: $120,000 - $150,000 per year, depending on location and experience.

About Us:

Enable Injections Inc is a leader in the medical device industry, committed to delivering innovative solutions that improve patient outcomes. Our team is passionate about developing and manufacturing high-quality products that meet the highest standards of excellence.



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