Under the direction of the Mfg. Manager or Designee, this position performs a variety of assignments related to the determination, maintenance, and improvement of efficiency, utilization, productivity, and quality of the assigned manufacturing work unit.
Perform engineering activities ensuring the accomplishments of production, quality and cost. Accountable for evaluation, troubleshooting, and product improvement process including product transfers, validations, and qualifications.
As required, and according to educational major and / or experience, supervision of specialized manufacturing support personnel may be assigned.
The manufacturing engineer position may indirectly supervise other positions if appointed as Team Leader of specific projects.
This position has daily contact with personnel at all levels within Zimmer Biomet. Comply with all established manufacturing control procedures in order to assure that final product will be in compliance with specifications approved in order to guarantee compliance with established production controls as required by 21 CFR 820, Subpart G Sec. 820.70.
Principal Duties and Responsibilities :
Provides engineering support and assists manufacturing personnel (e.g. Manufacturing Team Leader, Assembler, Technicians, Quality Engineer, etc.
in the timely evaluation and solution of manufacturing problems ensuring compliance with the established Quality System.
Responsible for the development and / or improvement of manufacturing methods and processes through the application of lean manufacturing techniques.
Evaluates, recommends, initiates, monitors, and / or implements corrective actions to maintain and / or improve efficiency, utilization, productivity, and quality at the assigned manufacturing work unit(s).
Evaluates and / or implements manufacturing process improvement ensuring the integrity of the established Quality System such changes and / or modifications of routings, work instructions, machinery and / or equipment modifications, etc.
Responsible for documenting the approved changes and / or modifications.
Responsible for personnel training on new methods, standards and / or changes.
Contributes to the work areas efforts to reduce and / or eliminate scrap, and evaluate, respond, and implement corrective actions to resolve customer complaints.
Assists in the evaluation, analysis and continued improvement of quality indicators.
Principal Duties and Responsibilities
Improve, upgrade, and modify assembly and test fixtures to assure manufacturability of products and active involvement in troubleshooting for the solution of any problem related to testing equipment, assembly fixtures, or processes.
Plans and organizes work areas activities to meet or exceed Zimmer Biomet transfer schedules. Coordinates the key activities which relates to these transfers, with Manufacturing, Engineering, Design, Quality and Production Control functions.
Support Product and Process transfers ensuring all required documentation are available and updated, and perform required validations and qualifications of any new or transferred process, equipment or product.
Responsible for the evaluation of process, machinery, and / or equipment problems affecting production, quality, and / or service.
Develops and implements corrective actions. Accountable for the evaluation of new and / or changes in the material, process, tooling, and / or machinery and / or equipment.
Initiates and / or assists in the evaluation and / or preparation of Zimmer Biomet Capital Appropriation Request (CAR) documentation for cost reduction and / or improvement projects related to the assigned manufacturing work unit(s).
Identifies, recommends, implements, and documents improvements in procedures, methods, or equipment in order to meet or exceed the established Cost Reduction Plan goals.
Develop required process and plant layouts for improved manufacturing operations, and space optimization; perform time studies for standard time development and line balancing.
This position is responsible for the timely and reliable manufacturing support in annual Standards Cost Revisions and other Financial / Systems activities such physical inventory count, implementation of new or revised procedures for cost and information systems.
The Engineer Manufacturing position is responsible for ensuring a clean environment, accident free working environment as well as compliance with Local and Federal Safety and Environmental regulations as applicable to Zimmer Biomet.
Depending on work area necessity may be required to supervise a manufacturing work unit to cover for vacations and / or other personnel related Business circumstances.
Maintain Supervisor or Designee informed all time for any deviation in process that might affect product performance and their quality.
Those imply but not limited to problems with the material, parts, components, products, equipment, machinery or tools that are affecting or may adversely affect the quality and quantity of work.
Responsible for support and enact continuous improvement initiatives; promotes continuous improvement culture throughout the creativity development, improvement recommendations, kaizen event participation and the sustainment of improvement activities implementation.
Ensure to maintain a good Team work relation and promote Best Manufacturing Practice.
Responsible for the use and care of Personal Protective Equipment (PPE) and / or safety devices installed in manual, automatic and / or semi-
automatic machinery, as indicated by Occupational Safety.
Ensures to meet the established Policies, Procedures and Company Rules, Occupational Safety and Physical Plant, Quality, Environmental, Finance, and others.
Notify the Supervisor and / or Designee damaged equipment and any situation that may present a risk to occupational safety and / or the proper functioning of the machinery and / or equipment in the area.
Assumes additional duties and responsibilities related as required and assigned by the Supervisor or Designee.
Expected Areas of Competence
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and / or ability required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Bilingual-(English and Spanish) Ability to read and interpret documents such as price lists, catalogs, requisitions, vendor quotes and invoices, and engineering drawings.
Ability to write routine reports and attention to details.
Ability to speak effectively to vendors and employees of the organization.
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.
Ability to apply concepts of basic algebra and geometry. Background statistical knowledge.
MS Office knowledge (Excel, Word, Power Point, Visio).
Excellent negotiation and communication skills.
Must be able to manage multiple short and long-term projects simultaneously.
Ability to communicate technical information and deliver information, specifications, and interact with people.
Ability to work in a team environment.
Manual skills and the ability to follow instructions consistently required.
The noise level in the work environment is usually moderate.
The work requires routine walking, standing, bending, sitting and carrying items weighing up 50 pounds.
Lean manufacturing and six sigma knowledge.
Education / Experience Requirements
Bachelor’s Degree in Engineering Electrical, Mechanical or Industrial Engineering preferred.
Three to five years experience in the Medical Device / Pharmaceutical industry.
Six Sigma, Lean Manufacturing and Project Management knowledge and experienced, preferred.
Process validation and qualifications experienced (IQ, OQ, & PQ).
Knowledge of QSR, GMP, ISO regulations and documentation control.