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Process Improvement Engineer

Indianapolis 80K - 100K p/h Permanent

Job Responsibilities:

  • Support continuous improvement projects, root cause analysis, and capital improvements
  • Responsible for engineering-related support of manufacturing equipment and processes including continuous improvement, scrap reduction, and capacity improvements or optimization
  • Lead project teams to increase productivity, reduce scrap, implement lean manufacturing, and improve system availability, safety, and product quality
  • The ability to recognize opportunities and appropriately prioritize projects based on potential improvement and risk is imperative
  • Perform root cause investigations for CAPA processes
  • Report findings to cross-functional team, propose and implement corrective actions, and verify corrective action effectiveness
  • Develop SOPs for equipment operation, part inspection, equipment changeover, and preventive maintenance activities that are current and accurate
  • Work with vendors to provide quotes and identify system specifications
  • Coordinate project timelines to meet manufacturing requirements
  • Write, Review, and Execute PVP, IQ, OQ, PQ, FMEA, and RA documents and summaries
  • Familiarity with cGMPs, ISO, and other Medical Device Industry regulations and specifications
  • Support manufacturing by diagnosing system or process failures and working with Maintenance and/or the Tool Room personnel to implement system fixes


Qualifications:

  • Bachelor's degree or equivalent in Biomedical, Mechanical, or Manufacturing Engineering
  • 3+ years' of industry experience
  • Experience with IQ/OQ/PQ, FMEA, and RA is preferred
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