- Lead, create, and execute the OpEx strategy and roadmap for current and future budget years
- Support the PU Warrendale leadership team in identifying, prioritizing, and delivering operational excellence improvements
- Direct and support site OpEx improvement programs to improve regulatory compliance, cost, and growth of MedTech devices and spare parts
- Own the PU Warrendale improvement roadmap
- Establish and manage the site OpEx team and report weekly achievements
- Lead project teams to deliver against plant EBIT targets using appropriate methodologies
- Coach Lean Six Sigma belts and provide plant-wide technical support for project analysis
- Conduct annual belt training for new hires
- Maintain the plant scorecard of critical performance metrics
- Manage project spending against approved budgets
- Supervise external continuous improvement consultants with the site leadership team
- Partner with Manufacturing, Quality, Operations, Supply Chain, and other plant functions to drive local changes
- Manage OpEx project resources with local site leadership
- Ensure projects use appropriate Lean/Six Sigma methodologies, including DMAIC, process controls, and statistical analyses
- Define and implement financial tracking of OpEx results
- Develop Lean/Six Sigma training and implementation and share best practices
- Achieve goals and report key outputs to plant and regional management
- Ensure compliance with Health, Safety, Environment, Energy, and Quality Management Systems
Requirements
- English is the company’s primary business language; must effectively speak, read, write, and understand English
- Ability to prioritize and work independently with little to no supervision
- B.S. degree in Engineering, Life Sciences, or a Finance-related field required
- 10 years of overall experience managing improvement processes and complex projects
- 5 years of medical device, pharmaceutical, life science, or other manufacturing experience within a cGMP environment preferred
- 3 years of experience in electro-mechanical operations preferred
- Lean Six Sigma Black Belt certification or equivalent experience required
- 3 years of successfully leading continuous improvement projects and delivering tangible results required
- Excellent analytical and technical skills
- Excellent written and verbal communication skills
- Ability to communicate and interact with all organizational levels and manage in a dynamic environment
- Must be currently authorized to work in the United States for any employer and maintain that authorization without employer sponsorship
Core Competencies
Demonstrates expertise in Lean Six Sigma methodologies, project management, and operational excellence within a regulated environment. Proven ability to lead cross-functional teams, drive continuous improvement initiatives, and achieve measurable results in the MedTech or manufacturing sectors.
Highest-signal resume keywords
- Lean Six Sigma Black Belt Certification
- Operational Excellence Strategy Development
- Project Management in cGMP Environment
- Continuous Improvement Leadership
- Regulatory Compliance Management
ATS Optimization Keywords
Hard Skills
- Lean Six Sigma Methodologies
- DMAIC Process
- Statistical Analysis
- Project Budget Management
- Performance Metrics Tracking
- Electro-Mechanical Operations
- Technical Support for Project Analysis
- Regulatory Compliance
- Operational Excellence Improvement
- Analytical Skills
Soft Skills
- Excellent Written Communication
- Excellent Verbal Communication
- Ability to Work Independently
- Interpersonal Skills
- Dynamic Environment Management
Certifications & Qualifications
- Lean Six Sigma Black Belt Certification
Industry Keywords
- MedTech Devices
- Pharmaceutical Manufacturing
- Life Sciences
- CGMP Environment
- Health and Safety Compliance
- Quality Management Systems
- Continuous Improvement Consultants
- Plant EBIT Targets
- Operational Excellence Team Management
- Manufacturing Operations