The working scope of a Manufacturing Engineer is to optimize and support the manufacturing process of the company’s products and services. Included in these responsibilities: create, document, develop, and implement processes and procedures required to assemble, test, and manufacture the products of the company while adhering to all safety, quality, regulatory and customer requirements.
- Develops, evaluates, improves and eliminates waste in all manufacturing processes, utilizing Lean Manufacturing and Six Sigma techniques.
- Develops and implements process control techniques and procedures into manufacturing environments.
- Analyzes manufacturing process flows and floor layout for the enhancements of safety, quality, cost reduction, and throughput.
- Creates and implements manufacturing cells when applicable.
- Collaborates with quality control and design engineering regarding product tooling, gaging and design to ensure effectual production methods necessary to achieve zero defect, low product cost and standard work.
- Estimates resource requirements, production times, and relative costs to provide data for operational decisions.
- Works closely with manufacturing departments to develop, coordinate, and implement technical training for employees.
- Creates and maintains tool, fixtures and functional gauges to support manufacturing.
- Processes ERP system data to support shop floor activity.
- Provides engineering support to the production department to troubleshoot and resolve technical problems.
- Supports company policies and procedures, goals and objectives, FDA regulations, and good manufacturing practices.
- Assists in design reviews, PMFEA, FMEA activities.
- Assists in Root Cause Analysis for non-conformances and Corrective Actions
- Assists in providing data-driven solutions for process improvement.
- Assists in field investigations and remediation for RMA Team.
- Assists in IQ/OQ/PQ Validations.
- Assists with DCN Process.
- Assists/Leads projects for Lean / Six Sigma Initiatives.
- Provides capital equipment justifications.
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES
- Extensive experience in CNC processes.
- Strong background in Process Improvement.
- Knowledge of Lean / Six Sigma methodology.
- Knowledge of CAD CAM for designing and manufacturing.
- Knowledge of SPC tools and processes.
- Knowledge of Cellular Manufacturing.
- Blue Print reading including GD&T dimensioning.
- Proficient in 3D Modeling, fixture development and tooling optimization.
EDUCATION AND EXPERIENCE
- Bachelor’s degree or equivalent experience in a related field.
- Minimum of 5 years’ experience in a manufacturing or machine shop environment.
- Secondary process experience (welding, polishing, electropolish, passivation, assembly) required.
- Ability to develop a 3D model, write the CNC program, and build the prototype is preferred.
- Silicone molding experiencepreferred.
- Lean project experience in cost reduction/process optimization required.
- Medical industry background preferred.
Job Code: 1943