Sr Lead Engineer

• Career development with an international company where you can grow the career you dream of.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

• Daily support to the manufacturing activities in order to meet established goals for safety, quality, cost and production. Manage and lead complex projects.
• Performs risk analysis to improve KPIs. Based on key performance indicators data such as yield, nonconforming material or lead-time, takes action to maintain indicators under control. Utilize and is able to coach others in the use of capability tools like Gage R&R, Cp, Cpk, and SPC to improve processes. Understands product cost components and its interactions, ie direct & indirect material costs, MUV, labor, overhead. In addition, understand manufacturing concepts and tools like Value Stream mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput.
• Uses statistical techniques to facilitate decision making and to draw conclusions from available data. Prepares product and process reports by collecting, analyzing, and summarizing information and trends.
• Evaluation of production equipment. Identifies, selects, and purchases equipment/fixtures according to production requirements, due to obsolescence, redundancy or line capacity expansion. Not only production requirements but product specification requirements. 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 withing financial cycle. Refer to budget execution as planned and management as per LBE process. Protocol and report writing.
• Keeps equipment operational by coordinating calibration, maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service when needed.
• Analyzes equipment data, trends, and performance to assure correct lifecycle management. Identifies and mitigates risks associated to equipment technical knowledge, spares availability and external technical service.
• Has knowledge and expertise on product/ components materials design requirements and specifications. 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. Refer to budget definition and execution as planned and management as per LBE process for process changes.
• Assures that production lines output meets the specifications of the product and process. Has clear criteria of conforming/ non-conforming product and the test methods used for verifying conformance. Maintains MP's current and compliant to regulations. Ensures practices at the manufacturing floor adhere to them. Assess that training requirements ensure adequate product assembly and supports DL's & IDL's training process.
• Able to navigate and execute activities on manufacturing systems for example, update routers, BOM's or to generate new part numbers and ZFINs. Interface with vendors for incoming components. Coordinates the activities related to new ZFIN's implementation.
• Leads local and global cross functional team activities. Supports global initiatives with other functions and sites (ie, RA, R&D, QA).
• Uses and is able to coach others in Root cause problem solving techniques to identify and eliminate causes, implements controls and define preventive activities. Leads, coach and supports CAPA investigation processes, or exception documents such as complaints investigations.
• Design, develop and implement manufacturing processes leap improvements, tooling, and fixtures in order to meet daily production schedules while improving yield, unit cost, productivity and product quality.

• Bachelor’s degree in engineering.
• 9+ years of manufacturing engineering/process development experience.
• Statistical techniques knowledge (DOE, SPC) is required.
• Computer software knowledge (Microsoft Word, Excel, Power Point).
• Willing to travel.
• Fully Bilingual (English and Spanish) / Required
• Experience with continuous improvement methodologies. Such as lean manufacturing techniques, value stream mapping, or similar.
• Knowledge of FDA, GMP, and ISO guidelines is required.
• Medical device experience preferred.
• Strong analytical, problem solving and project management skills.
• Demonstrated leadership capability in team settings.
• Experience leading validation plans for medical industry products and processes and leading root cause problem solving methodologies.
• Experience in project management.
• Six Sigma certification preferred.

• 7+ years prior experience in medical devices manufacturing.
• Performance management

Abbott