Staff Engineer, Manufacturing

Enable Injections

Cincinnati, US
On-site
Manufacturing equipment design and support
Fda validation experience
21 cfr 820 knowledge
Enable Injections is seeking a Staff Engineer with extensive experience in manufacturing engineering, specifically within regulated industries such as medical devices or pharmaceuticals. The ideal candidate will have a strong background in FDA validation, process design, and equipment troubleshooting, along with leadership abilities to manage cross-functional teams and projects

Job Summary

  • Lead process design and optimization through design of experiments and engineering studies.
  • Troubleshoot and implement solutions to aid in the manufacture of the product, requiring changes to assembly equipment and/or the modification of part/mold design and inspection criteria.
  • Author Quality System documentation to support all of the responsibilities above, including but not limited to change control, engineering change orders, equipment forms, calibration forms, and preventive maintenance forms.

Matching Summary

Match Score: 85

Enable Injections is seeking a Staff Engineer with extensive experience in manufacturing engineering, specifically within regulated industries such as medical devices or pharmaceuticals. The ideal candidate will have a strong background in FDA validation, process design, and equipment troubleshooting, along with leadership abilities to manage cross-functional teams and projects.

Skills & Requirements

Must-have

  • Manufacturing equipment design and support
  • FDA validation experience
  • 21 CFR 820 knowledge
  • Medical device product development
  • Process design and optimization
  • Troubleshoot manufacturing issues

Nice-to-have

  • High-volume manufacturing experience
  • Medical device inspection technologies
  • Lean Six Sigma Certification
  • Foster teamwork and collaboration
  • Technical coaching and leadership

Key Requirements

  • Bachelor's Degree in Engineering or related field
  • 8 years manufacturing engineering experience
  • 1 year FDA validation experience
  • Master's degree + 6 years experience

Work Rights

Not specified

Tailored Resume

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