Manufacturing Engineer 1

This is a full-time position to work Monday - Friday in our Heredia site located in Zona Franca Metropolitana.
Remote work might be allowed based on business needs.
Main Purpose of Job: (Brief Summary)
Responsibilities
Under the direction of the Director of Manufacturing Engineering, Engineering Manager (Product Launch or Sustaining), Value Stream Manager (VST) or Designee, our
Manufacturing Engineer 1
is responsible for:

• Providing engineering support to all required manufacturing/engineering areas in order to improve processes and provide immediate solutions to any problems that may affect process performance in areas such as assembly, printing, quality, special projects, etc.
• Supporting the engineering and technical needs of the campus and customers (strategic and tactical, such as value improvement projects, new process / equipment, etc.).
• Designing and implementing fixturing, tooling and methodologies to support manufacturing and production efficiencies.
• Analyzing current manufacturing methods and practices in order to identify opportunities to eliminate non-value added steps; recommending, developing and prototyping new processes and production methods to enhance manufacturing. Discerning when and how to use Lean
• Manufacturing techniques: 5S, waste identification and elimination, value stream mapping, Kaizen, error proofing, one piece flow, set-up time reduction, Kanban, balanced work flow, etc.
• Providing team leadership support for process improvement projects involving quality, productivity and cost reductions.
• Supporting product launches across the campus.
• The validation, implementation and controls to support manufacturing process transfers, relocations and changes.
• Analyzing current project plans and execute accordingly, ensuring achievement of expected quality levels, customer satisfaction and financial goals.

Main Job Duties/Responsibilities

• Support, promote and enforce safety across the campus. Support and promote the overall EHS initiatives and programs.
• Follow all Good Manufacturing Practices (GMP's) and Standard Operating Procedures (SOP's) as defined by MedPlast's policies, practices and procedures to ensure that FDA and ISO regulations along with MedPlast quality standards are met.
• Identify processes improvements and as applicable; plan, design and implement methods (including line/workstation reconfigurations, tools, fixtures and others) to meet quality specifications and productivity goals of the current and/or new business supported. Continuously seek for product/process improvement projects, relevant to Lean Manufacturing and Innovation.
• Provide budgetary, costing and other data to support the decision making process prior to the implementation of a new process or process change.
• Drive product/process compliance investigations for non-conformances (NCs), Corrective and Preventive Actions (CAPAs) and Internal/External Audits; and ensure timely completion and effectiveness of implemented actions.
• Prepare and present reports on accomplished tasks. Perform applicable recommendations based on those reports.
• Troubleshoot existing manufacturing processes for quality and productivity issues.
• Update existing Device Master Records and Device History Records for the assigned manufacturing areas (documentation required for manufacturing). Prepare and update work instructions and any applicable documentation required to sustain manufacture (Bill of Materials,
• Routings, Manufacturing Work Instructions, Labeling Specifications, etc.).
• Execute qualifications (IQs/OQs/PQs/PPQs/TMVs) with an approved protocol; gather data and analysis results for completing the corresponding report.
• Train manufacturing and quality assurance personnel in the assigned processes, validation protocols and the proper use of fixtures and any other required equipment.
• Support Value Stream Team members on the initial stages of the production launch of each project, in terms of quality issues, yield and productivity.
• Complete time and motion studies in order to define labor standards for the assigned manufacturing area, balance and optimize workloads.
• Attend and coordinate meetings to plan and share information related to Engineering, Quality, Regulatory and Project affairs.
• Perform other duties, tasks, or projects at the direction of immediate supervisor and not limited to the job category.

Knowledge / Education / Job Experience

• Minimum education required to perform duties: Bachelor degree in Engineering (i.e. Mechanical, Manufacturing, Industrial Engineering or science related engineering discipline, etc.)
• Proficient in Microsoft Office.
• Bilingual English/Spanish – Basic English level, reading comprehension and writing.
• Basic knowledge and application of statistical techniques (basic descriptive statistics).

• Additional Knowledge as a Plus

• Proficient in CAD software (AutoCad or SolidWorks) is a plus.

• Knowledge of Minitab statistical software is a plus.

• Experience within the medical device manufacturing field or in any other regulated industry is a plus.

• From 0 to 1 year work experience.

Skills / Competencies
Good interpersonal skills and the ability to communicate orally and in writing.
Self-motivated.
Organized and able to manage multiple tasks and priorities.
Must be able to read and understand specifications. Proficient in the interpretation of technical drawings.
Must be able to work and effectively communicate with others.
Highest ethical standards and professional integrity.
Able to work independently.
Teamwork oriented.
Decision making: Must be able to quickly and independently make decisions. Hands
-on, collaborative, decisive.

Must be flexible and adapt to changing environments and priorities.

Problem Solving: Basic understanding of problem solving methodology.

Metrology: Basic knowledge of measurement and error theory, and measuring instruments and equipment.

Viant es un proveedor global de servicios de diseño y fabricación de dispositivos médicos que se asocia e innova con los clientes para proporcionar la más alta calidad, dispositivos médicos que mejoran la vida de las personas. Hacemos esto a través de nuestra profundidad y amplitud de capacidades, integración de extremo a extremo, experiencia técnica y enfoque implacable en nuestros clientes y en la excelencia operativa. Con casi 6.000 asociados en 24 ubicaciones en todo el mundo, ofrecemos una combinación única de servicio y atención a pequeñas empresas con recursos de grandes empresas. Para más información, visite o síganos en LinkedIn.

Viant proporciona igualdad de oportunidades de empleo (EEO) a todos los empleados y solicitantes de empleo sin tener en cuenta la raza, color, religión, género, orientación sexual, nacionalidad, edad, discapacidad, estado civil, amnistía, o estatus como veterano cubierto de acuerdo con las leyes federales, estatales y locales aplicables. Viant cumple con las leyes estatales y locales aplicables que rigen la no discriminación en el empleo en todos los lugares en los que la empresa tiene instalaciones.