The Manufacturing Engineer is responsible for optimizing and supporting 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.

Essential Duties and Responsibilities:

• 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.
• Process 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.
• Assist with design reviews, PMFEA, FMEA activities, root cause analysis for non-conformances and corrective actions.
• Provide data-driven solutions for process improvement and field investigations, remediation's for RMA Team as needed.
• Involved with IQ/OQ/PQ Validations and DCN Process.
• Lead projects for Lean / Six Sigma Initiatives and provides capital equipment justifications.

Qualification Requirements

Education and Experience:

• Bachelor's degree in Mechanical, Industrial or Manufacturing Engineering or equivalent degree and experience in a related field, preferred.
• Minimum of 5 years' experience in a manufacturing, machine shop or tooling manufacturing environment, required.
• Secondary process experience (welding, polishing, electropolish, passivation, assembly) preferred.
• Ability to develop a 3D model using Solidworks or similar software, preferred
• Write the CNC program using Mastercam or similar software preferred.
• Silicone molding experience preferred.
• Lean project experience in cost reduction/process optimization 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 (Solidworks, or other), fixture development and tooling optimization.

Other Requirements

Mental Requirements:

The work environment is representative and typical of similar jobs in comparable organizations.

Physical Requirements:

While performing the duties of this job, the employee could be required to stand. The employee could frequently be required to walk; use hand to finger, handle, or feel; reach with hands and arms and talk or hear. The employee could be required to sit; climb or balance and stoop, kneel, crouch, or crawl. The employee could occasionally lift and or move up to 50 pounds. Specific vision abilities required by the job could include close vision, distance vision, peripheral vision and ability to adjust focus.

Americans with Disabilities Act (ADA):

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of the Company.