Summary of Position with General Responsibilities:
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.
•Must be fully bilingual (English/Spanish) and must have good communication skills both oral and written
•Must have knowledge of 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
•Strong background in statistical Process Control
•Excellent analytical, organizational interpersonal, written and verbal communication skills.
Additional Desirable Qualifications Skills and Knowledge:
•Puerto Rico registration certification (PE) to practice the profession is desired
•Six Sigma Black Belt highly desirable.
Education and/or Experience:
•College degree in Engineering, preferably in Chemical, Industrial or Mechanical Engineering
•Must possess 3-5 years of experience as a Manufacturing Engineer in a Medical Device manufacturing environment, preferably with tool and machine design experience
•Experience in capital appropriation evaluation and analysis.
- Hours of operation are flexible and vary depending on job requirements. Typical work week is 40 hours with additional/variable hours for specific work periods and projects. Specific work days and hours are flexible and may change with advance notice
- The nature of the work requires exposure to chemicals, noise. Exposure to machinery and non-ionizing radiation
C. R. Bard is no upstart in the world of medical devices. The company has been in the business for more than a century and introduced the...