Manufacturing Engineering Section Leader

  • Alajuela
  • Abbott Laboratories

Position for Shift B

MAIN RESPONSABILITIES

  • 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
  • Understand 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 equipment, process, product and test method validations.
  • Estimates validation activities cost and assures it is budgeted within the financial cycle.
  • Looks for and applies industry best practices related to equipment and process qualification.
  • Assures manufacturing lines have equipment requirements fulfilled according to the 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/non-conforming 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.
  • Suppors 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.
  • RCPS Subject Matter Expert
  • Experience with continuous improvement methodologies. Such as lean manufacturing techniques, value stream mapping, or similar.
  • Solid knowledge of FDA, GMPs, and ISO regulations. Is required
  • At least 2+ years of experience managing exempt technical personnel (Engineers)
  • Experience leading teams and 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 and Spanish)
  • 5 years prior experience in medical device manufacturing preferred.
  • Performance management experience
  • Experience working on product ramp-ups under a pressure environment in order to meet goals and KPIs.