Abbott

Sr Manufacturing Process Engineer (BB-FDE4A)

Encontrado en: Neuvoo CR

Descripción:

MAIN PURPOSE OF ROLE

The process engineer position develops and implements optimal, cost-effective manufacturing process and method improvement and changes in accordance with product specifications and quality standards. Performs analyses to develop design specifications and performance requirements. Provides technical information concerning manufacturing or processing techniques, materials, properties and process (advantages/limitations) engineering planning. Selects techniques to solve problems and make sound design recommendations.

MAIN RESPONSIBILITIES

  • Based on key performance indicators data such as yield, nonconforming material or leadtime, may support activities focused on maintaining indicators under control.
  • Prepares product and process reports by collecting, analyzing, and summarizing information and trends.
  • Uses statistical techniques to facilitate decision making and to draw conclusions from available data.
  • Understands product cost components and its interactions, ie direct & indirect material costs, MUV, labor, overhead. Uses product cost knowledge to identify risks and opportunities.
  • Evaluate the design and execute the implementation of new processes following “Design for Manufacturability” principles and understanding work environment issues (i.e. OSHA regulations, etc.).
  • Performs installation/validation activities for new or existent production lines meeting regulatory requirements. That includes equipment, process, product and test method validations.
  • Estimates validation activities cost and assures it is budgeted within financial cycle.
  • Coordinate the creation and implementation of equipment specifications and drawings following company policies.
  • In cases when non-product software is required, seeks for the appropriate support from Software Quality Engineering ensuring the appropriate validation and source code storage following quality procedures.
  • Identifies, selects, and purchases equipment/fixtures considering production requirements, mass production implications, redundancy or line capacity expansion. Has direct relation with vendors to define equipment suitability.
  • Keeps equipment operational by coordinating calibration, maintenance and repair services. Analyzes equipment data, trends, and performance to assure correct lifecycle management. Uses historical data to drive future equipment selection.
  • Responsible for the activities related to installation and validation of production lines as well as the lifecycle management of equipment
  • Maintain knowledge of new developments in manufacturing and design technologies
  • Has knowledge and expertise on product requirements and specifications. Understands potential risks related to product malfunctions. Evaluates the financial or process/product quality impact, derived from product & process changes. Uses statistical techniques to facilitate decision making and to draw conclusions from available data.
  • Assures that production lines output meet the specifications of the product.
  • Has clear criteria of conforming/ non conforming product and the test methods used for verifying conformance.
  • Able to navigate and execute activities on manufacturing systems for example, update routers, BOM's or to generate new part numbers and ZFINs. Coordinates the activities related to new ZFIN's implementation.
  • Maintains MP's current and compliant to regulations. Ensures practices at the manufacturing floor adhere to them. Supports DL's & IDL's training process.
  • May lead or serve as member on cross-functional project teams including local and global participants (i.e. RA, R&D, DQ, etc). Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Responsible for researching new technology and suggesting new machines to the appropriate purchasing managers and decision-makers.
  • Participates in the identification and investigation of Non-conforming products. Uses root cause problem solving techniques to identify and eliminate causes, implement controls and define corrections, corrective actions and preventive actions. Leads or supports CAPA investigation processes, or exception documents such as complaints investigations.
  • Identify and implement continuous improvement projects for any of the main key areas: safety, quality, production and cost, using the appropriate project management tools.
  • May supervise and/or provide technical assistance and work direction to exempt and non-exempt personnel, being accountable for their correct training and performance management.
  • Provides inputs for the departmental budget preparation.
  • QUALIFICATIONS

  • Bachelor's Degree in Engineering
  • 7+ years of manufacturing/process development experience
  • Experience developing manufacturing processes and technologies and designing for manufacturability preferred
  • Previous project management experience
  • Experience working in a broader enterprise/cross-division business unit model preferred
  • Statistical techniques knowledge (DOE, SPC, Minitab software or equivalent) is required.
  • Computer software knowledge (Microsoft Word, Excel, Power Point).
  • Experience with continuous improvement methodologies such as lean manufacturing techniques, value stream mapping, or similar.
  • Knowledge of FDA, GMP, and ISO guidelines is required.
  • Experience leading validation plans for medical industry products and processes and leading root cause problem solving methodologies.
  • Advanced level of English
  • calendar_todayhace 1 día

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    location_on Alajuela, Costa Rica

    work Abbott

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