Department: Logistics
Location: Gainesville, FL
Description
The Continuous Improvement Engineer will be responsible for developing and sustaining performance management systems, lean manufacturing practices, and continuous improvement initiatives across operations, fulfillment, and other departments as needed. This role will focus on optimizing workflow, improving material and information flow, and implementing standardized work at all levels. The Industrial Engineer will play a key role in fostering a culture of continuous improvement (CI) and data-driven decision-making within the organization, ensuring compliance with ISO 13485 and other relevant regulations.
Key Responsibilities
- Operational Excellence
- Develop and sustain performance tracking mechanisms and Tier Management Systems to improve operational transparency and accountability.
- Implement Leader Standard Work (LSW) and Operator Standard Work (OSW) to establish consistent, efficient processes.
- Utilize digital performance management tools (dashboards, real-time monitoring) to track key metrics and improve decision-making.
- Ensure all process improvements comply with ISO 13485 and other regulatory requirements.
- Optimize operations and fulfillment processes to improve safety, quality, delivery, cost and inventory.
- Continuous Improvement & Innovation
- Lead Lean Manufacturing and Continuous Improvement (CI) initiatives, driving process efficiency and waste reduction.
- Implement 5S, visual management, and Value Stream Mapping (VSM) to enhance operational effectiveness.
- Conduct Kaizen events and Gemba walks to identify and resolve inefficiencies in fulfillment, operations, and other supported departments.
- Train and mentor employees on Lean methodologies, problem-solving tools, and Six Sigma principles.
- Develop data-driven solutions for improving material and information flow across the organization.
- Compliance & Performance Management
- Ensure process improvements align with ISO 13485 and other industry regulations.
- Assist with FDA and ISO audits as needed, ensuring that all documentation and operations meet regulatory standards
Required Education, Experience, Skills, Credentials and Knowledge
Education- Bachelor’s Degree in a related field from an accredited institution required.
Experience- Minimum of 1-3 years in a production / manufacturing process-oriented environment is required
- Experience with Manufacturing Execution Systems is a plus.
Skills, Credentials, Knowledge- Must be skilled in the use of Lean Manufacturing and six sigma concepts
- Must be highly skilled in the creation and design of current and future state shop workflows and facility layouts in a CAD environment. UG experience preferred.
- Must be proficient in analysis and visualization tools such as PowerBI.
- Strong project management skills with experience using MS Project (Gantt charts) or similar tools.
- Green Belt certification preferred; if not currently held, must be obtained within the first year of employment.
- Strong analytical and problem-solving abilities with mechanical aptitude.
- Excellent organizational skills and ability to manage multiple projects simultaneously.
- Team-oriented mindset with strong communication and collaboration skills.
- Knowledge of ISO 13485 and regulatory compliance requirements for medical device manufacturing.
