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Hologic Manufacturing Engineer 3 CR in Alajuela, Costa Rica

Manufacturing Engineer 3 CR

Alajuela, Costa Rica

  • Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades:

  • Summary: Direct, coordinate and plan current and new manufacturing processes and generate - transmit knowledge for the proper implementation of the process in accordance with the quality requirements and guidelines established by FDA and ISO regulations, in order to maintain and improve the key performance indicators (KPI's Key Process Indicators), cost reduction and provide technical support to the production process, in order to solve, through the Problem Resolution System, the process opportunities due to assignable causes or systemic problems, in the areas of manufacturing, meeting the requirements of our quality system.

  • Promote a work environment focused on safety, operational excellence and provide value to both internal and external clients.

  • Leading problem-solving teams, collaborating with the organization and planning of activities, and providing support with technical knowledge such as SME, in order to attack problems with effective and systemic solutions.

  • Coordinate and review systemic quality problems at level meetings (Daily Administration and Standard Work) and propose and follow up on the action plans that are defined.

  • Develop Risk Analysis, Protocols and Validation Reports of current and new Processes, Equipment and Fixtures.

  • Provide provision to the NCE's of highly complex process and final product related to manufacturing processes where required as SME.

  • Lead and support Operational Excellence activities of the OPEX systems that apply to promote a culture of continuous improvement.

  • Monitor product metrics, especially those related to cost (Scrap) to implement or delegate mitigation, correction, and prevention actions to meet the established goal.

  • Coordinate, direct and plan interdisciplinary teams with significant impact on the strategic objectives of the company.

  • Encourage and ensure the execution of GEMBA visits with the aim of strengthening the continuous improvement of manufacturing processes.

  • Prepare workshops for the transfer of knowledge of manufacturing processes and problem investigation methodologies.

  • Gather, apply and transmit knowledge in the handling, repair and maintenance of equipment, tool and material handling, assembly / packaging procedures of the current and new process that allow to solve possible problems efficiently and effectively, and ensure the correct operation of the manufactured product.

  • Provide technical advice to the calibration department on the calibrated equipment to be used to ensure that they are suitable for manufacturing.

  • Provide technical support to production and quality, in order to solve process, raw material or equipment problems, helping to identify the root cause through the Problem Resolution System.

  • Analyze, develop and execute actions according to CAPA's opened by the quality department, in which they are related to engineering.

  • Make reports in the required frequency to the Manufacturing Engineering Manager in order to follow up on the projects and activities carried out during the week and / or month.

  • Ensure timely compliance with the provisions of the NCE's of materials and teach and develop other Manufacturing Engineers in the correct documentation to provide viable and timely solutions.

  • Define and train GEMBA staff as SME of the product and process in criteria of acceptance or rejection of raw materials, sub-assemblies, products, etc., in order to maintain constant and satisfactory quality results for our clients.

  • Generate and ensure the correct execution of continuous improvement projects for processes through SPR and PRC in order to increase productivity, reduce scrap and re-work, continuous improvement projects for both materials and the process

  • Review and update the existing quality documentation and prepare new documents and procedures that allow the integration of the new process to the company's quality system.

  • Participate in interdisciplinary teams with significant impact on the strategic objectives of the company.

  • Ensure the correct and timely execution of the actions defined in the interdisciplinary teams (CSPO), level meetings and management meetings assigned to Manufacturing Engineering. Ensuring a clear and effective definition / allocation of priorities and resources to meet the needs of internal and external clients, in your business unit.

  • Participate as an internal auditor to provide quality support and verify compliance with the ISO and FDA standards. Support the facility in ISO or FDA audits.

  • Qualifications / Cualificaciones:

  • Sizing People

  • Building Effective Teams

  • Focus on the client

  • Strategic Agility

  • Delegation

  • Priority setting

  • Education / Educación:

  • Bachelor´s Degree in Mechanical, Electromechanical, Industrial, Materials, Chemical, Electronic Engineering or related discipline. Desirable Master´s Degree.

  • Experience / Experiencia:

  • Minimum experience of 5 years as a professional in the technical field and in positions of a similar nature and / or a minimum of 4 years of experience in the Medical Industry

  • Specialized Knowledge (Desirable) / Conocimiento especializado (preferible):

Project administration or management, OPEX, Advanced Statistics (Black Belts-CQE desirable). Knowledge related to ISO 50001 energy management systems.

  • Languages required for the position (Desirable) / Idiomas requeridos para el puesto (preferible):

English: > = B2

  • Computer tools and knowledge level required (Desirable) / Herramientas informáticas y nivel de conocimiento requerido:

  • Microsoft Office: Medium level

  • Other Tools: SolidWorks, Minitab, Project Manager, Visio

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