Principal Engineer, OpEx
$112k - $154kBaxter
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
Vacancy posted 1 day ago
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