POSITION SUMMARY

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.

PRINCIPAL RESPONSIBILITES

• 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 experience preferred.
• Lean project experience in cost reduction/process optimization required.
• Medical industry background preferred.

PHYSICAL DEMANDS

While performing the duties of this job the employee is frequently required to stand, sit, walk, talk, and hear. The employee is occasionally required to reach with hands and arms, stoop, kneel, or crouch.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

MISCELLANEOUS:

The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.

The job description does not constitute an employment agreement between the employer and the employee and is subject to change by the employer as the needs of the employer and requirements of the job change.