Manufacturing Engineer

About the role

The Manufacturing Engineer is responsible to provide technical support and improve processes to minimize costs. In addition to this, he/she designs production tools and/or machines and develops solutions to production problems relating to materials, processes and tooling. Shall be capable to manage difficult Manufacturing processes problems through a well and sound solution methodology. Must be able to comprehend and fully apply new technological developments.

Essential Job Functions

• *Designs tools and/or machines of varying types (some of a very complex nature) for use in the manufacturing of company products. Obtains approvals and builds the necessary tooling of products when required
• *Re-designs, repairs, or replaces in-process production program equipment, production controls hardware, and tooling
• *Develops processes, methods, tooling, and production controls for new programs; supervises their assembly and proofing
• *Sets-up new equipment, ensures its satisfactory operation, and instructs others to use the new equipment properly
• *Writes procedures for the operation of new or existing equipment
• *Recommends incorporation of new technology for Company applications where feasible and practical
• *Organizes and directs products and technology transfers to Puerto Rico facility from R & D center and other manufacturing facilities
• *Develops and implements process improvements and optimization through statistical process control and/or design of experiments
• *Maintains process sheets, specifications, bill of materials, drawings, operating procedures and any other documentation needed to manufacture, test or purchase products

*Provides in coordination with the Maintenance Supervisor all facilities and resources during the first production steps to assure on time start-up of new production items. Investigates availability of adequate machines accessories, tooling supplies, safety features, inspections gages and training

• *Assists in establishing annual tooling and capital investment budgets, selects, proposes and justifies purchase of major capital equipment
• *Assists in the training of less experienced department personnel
• *Introduces lean concepts as required or assigned throughout the manufacturing facility or other areas
• *Lays out applicable departments to establish optimum material flow, space usage and work station layout
• *Assures machine capability and utilization
• *Plans, writes, coordinates, executes, and summarizes validation protocols: Installation Qualifications, Operational Qualifications, Performance Qualification, Results and obtains approvals
• *Manages project planning and execution
• *Motivates, manages and develops personnel in a team environment*

• Assures is trained before performing any task
• Uses the required clothes, personal and security protective equipment according to the requirements of its operation
• Complies with the cGMP's, Quality Standards and established policies and/or procedures
• Executes other duties assigned by Supervisor.

Minimum Education and Experience

• *College degree in Engineering, preferably in Mechanical, Industrial or Chemical Engineering
• *Must possess 2-5 years of experience in a manufacturing environment, preferably with tool and machine design experience
• *Must be fully bilingual (English/Spanish) and must have good communication skills both oral and written
• *Must have knowledge o f cGMP's, OSHA, and ISO 9000 requirements and continuous Process Improvement techniques
• *Strong knowledge and experience in packaging method such as heat sealing, thermoforming and thermoplastic
• *Experience in capital appropriation evaluation and analysis is desired.

• *Strong background in statistical Process Control
• *P.C. literate
• *Teamwork oriented

Additional Desirable Qualifications Skills and Knowledge

• *Six Sigma Black Belt highly desirable.
• *Knowledge of project management tools is desirable.