Section Lead, Manufacturing Engineer
Abbott
Alajuela, Costa Rica
hace 2 días

MAIN PURPOSE OF ROLE

  • Provides leadership to engineering or cross functional teams to meet the business results. The manufacturing engineer position develops and implements optimal, cost-effective manufacturing processes and methods in accordance with product specifications and quality standards;
  • recommends and implements improvements to production processes, methods and controls; is also responsible for the activities related to instalation and validation of production lines as well as the lifecycle managment of equipments.

    MAIN RESPONSIBILITIES

  • Provides leadership to engineering staff regarding project prioritization, process validations, and continuous improvement activities.
  • Leads the team to maintain Key performance indicators under control.
  • Provides prioritization & allocates engineering resources, according to business needs.
  • Prepares product and process reports by collecting, analyzing, and summarizing information and trends.
  • Understands financial structure of the organization and its interactions with results.
  • Uses product cost knowledge to identify risks and opportunities.
  • Performs installation / validation activities for new or existent production lines, meeting regulatory requirements. That includes equipments, process, product and test method validations.
  • Estimates validation activities cost and assures it is budgeted withing financial cycle.
  • Looks for and applies industry best practices related to equipment and process qualification.
  • Assures manufacturing lines have equipment requirements fullfilled according to production plan.
  • 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.
  • Understands potential risks related to product malfunctions.
  • Evaluates the financial , process or quality impact, derived from product & process changes.
  • Uses statistical techniques to facilitate decision making and to draw conclusions from available data.
  • Has knowledge and expertise on product requirements and specifications.
  • Assures that production lines output meet the specifications of the product.
  • Has clear criteria of conforming / nonconfomring product and the test methods used for verifying conformance.
  • Able to navigate and excecute 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.
  • Leads or supports local cross functional team activities.
  • Participates with external cross functional teams(ie, RA, R&D, QA) representing the ME function. .
  • Leads global initiatives with other functions and sites.
  • Supports the team to meet quality indicators.
  • Leads or supports CAPA investigation processes, or exception documents such as complaints investigations, NCMR's.
  • Leads complex projects as project manager : New product introduction, substantial product changes, line expansions, etc.
  • Identifies and implements continuous improvement projects for any of the main key areas : safety, quality, production and cost.
  • May supervise and provide technical assistance 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 with statistical techniques (e.g., DOE, SPC). Is required.
  • Computer software knowledge (Microsoft Word, Excel, Power Point).
  • Willing to travel
  • Experience with continuous improvement methodologies. Such as lean manufacturing techniques, value stream mapping, or similar.
  • Solid knowledge of FDA, GMPs and ISO regulations.
  • Experience leading validation plans for medical industry products and processes and leading root cause problem solving methodologies.
  • Experience in project management involving coordination of cross-functional teams.
  • Fully Bilingual (English / Spanish). Required.
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