Senior Engineer

3 weeks ago

Cincinnati, Ohio, United States Enable Injections Inc Full time

Job Overview:

We are seeking an experienced Senior Process Engineer to join our manufacturing team at Enable Injections Inc. As a key contributor to our commercial manufacturing operations, you will drive process improvements, lead cross-functional teams, and ensure compliance with regulatory requirements.

Key Responsibilities:

  • Manufacturing Support: Rapidly respond to downtime events, determine corrective actions, and implement improvements.
  • Continuous Improvement: Identify opportunities to improve yield, throughput, and labor efficiency, and lead implementation efforts.
  • Quality System Documentation: Author quality system documents, including nonconformance reports, CAPA plans, and change controls.
  • Root Cause Investigations: Lead product/process/equipment root cause investigations with a cross-functional team and determine scrap root causes.
  • 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: Train manufacturing operators.
  • Layout/Workflow: 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.

Compensation and Benefits:

Our competitive salary range is $120,000 - $150,000 per year, depending on location and experience. We also offer a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.

About Enable Injections Inc:

We are 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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