Principal Engineer, OpEx Job at Baxter, Skaneateles, NY

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  • Baxter
  • Skaneateles, NY

Job Description

Principal Engineer leading operational excellence and continuous improvement initiatives across manufacturing and operations at a medical device company. The role requires expertise in Lean and Six Sigma methodologies, project management, and regulatory compliance to drive efficiency and quality improvements.

Responsibilities

  • Lead continuous improvement initiatives to enhance efficiency, reduce waste, and improve product quality
  • Manage OpEx projects from inception to completion with cross-functional collaboration
  • Analyze operational data and performance metrics; prepare reports for senior management
  • Provide training and mentorship on Lean and OpEx methodologies; lead Kaizen events
  • Ensure regulatory compliance of CI activities with FDA, ISO 13485, and GMP standards

Requirements

  • Bachelor's degree in engineering, industrial engineering, or manufacturing
  • 7+ years in continuous improvement, process engineering, or operations management
  • Strong expertise in Lean Manufacturing and Six Sigma methodologies
  • Experience with medical device quality management systems and FDA/ISO regulations
  • Excellent analytical, problem-solving, and project management skills
  • Data-driven decision-making with proficiency in statistical analysis tools

Compensation: $112,000-$154,000 base annually

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