Position Summary:

The Principal Process Improvements Engineer leads the development and implementation of continuous improvement initiatives across the organization using Six Sigma, Lean, and Design for Six Sigma (DFSS) methodologies. This role will drive operational excellence, quality improvements, and efficiency gains through systematic process optimization and cultural transformation.

Responsibilities and Duties:

• Lead organization-wide continuous improvement initiatives and complex projects

• Design and implement Lean/Six Sigma programs aligned with business objectives

• Identify and prioritize improvement opportunities through data analysis and process mapping

• Drive waste elimination and process optimization across manufacturing and business processes

• Facilitate kaizen events and value stream mapping sessions

• Develop and track key performance indicators (KPIs) for process improvement initiatives

• Coach and mentor Green Belts and Black Belts in improvement methodologies

• Implement statistical process control (SPC) systems and monitoring

• Lead cross-functional teams in problem-solving and process optimization

• Develop and deliver Lean/Six Sigma training programs

• Create standard work and visual management systems

• Partner with Quality Systems to integrate improvements into QMS

• Support implementation of projects and digital transformation initiatives

• Collaborate with suppliers on supply chain optimization projects

• Report project outcomes and benefits to senior management

• Ensure compliance with regulatory requirements while driving improvements

Requirements:

• BS/ MS in Engineering, Operations Management, or related field

• Master Black Belt certification required

• 10+ years of experience in process improvement roles

• Proven track record of leading large-scale improvement initiatives

• Expert knowledge of Lean Manufacturing and Six Sigma methodologies

• Strong background in medical device manufacturing and quality systems

• Experience with FDA, ISO 13485, and GMP regulations

• Advanced proficiency in statistical analysis and quality tools

• Excellent project management and change management skills

• Experience with continuous improvement software and digital tools

• Demonstrated success in building continuous improvement culture

• Strong financial acumen and business process knowledge

• Excellence in facilitation and training delivery

• Project management software