Manufacturing Engineering Section Leader

**JOB DESCRIPTION:** -------------------- **About Abbott**  Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.   **Working at Abbott**   At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:   * 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.   **The Opportunity**   This position works out of our Costa Rica – Alajuela location in the Structural Heart Division.   As the **Manufacturing Engineering Section Leader**, you will provide 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 installation and validation of production lines as well as the lifecycle management of equipment.     **What You’ll Do**   **1\. Leadership and Team Management** * 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. * May supervise and provide technical assistance to exempt and non-exempt personnel, being accountable for their correct training and performance management. **2\. Process and Validation Management** * 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. * Looks for and applies industry best practices related to equipment and process qualification. **3\. Equipment and Maintenance Management** * Assures manufacturing lines have equipment requirements fulfilled 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. **4\. Financial Analysis and Continuous Improvement** * Understands financial structure of the organization and its interactions with results. Uses product cost knowledge to identify risks and opportunities. * Provides inputs for the departmental budget preparation. **5\. Compliance and Quality** * 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/nonconforming 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. * Supports DL's & IDL's training process. * Supports the team to meet quality indicators. * Leads or supports CAPA investigation processes, or exception documents such as complaints investigations, NCMR's. **6\. Information and Systems Management** * 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. * Prepares product and process reports by collecting, analyzing, and summarizing information and trends. **7\. Project and Cross-Functional Team Participation** * 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. * Leads complex projects as project manager: New product introduction, substantial product changes, line expansions, etc. **Shift Admin** **(Monday – Friday from 8:00 am to 5:00 pm)** Works **100% on site**  **Required Qualifications**  * Bachelor’s Degree in STEM careers.   * 7+ years of manufacturing/process development experience or demonstrated combination of experience / skills in equivalent or similar positions * 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 and Spanish) /  Required **Preferred Qualifications**  * 5 years prior experience in medical device manufacturing preferred. * Performance management [Apply Now](https://www.jobs.abbott/)   Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.  Connect with us at [www.abbott.com](http://www.abbott.com/), on Facebook at [www.facebook.com/Abbott](http://www.facebook.com/Abbott) and on Twitter @AbbottNews and @AbbottGlobal.  **The base pay for this position is** N/A In specific locations, the pay range may vary from the range posted. **JOB FAMILY:** --------------- Manufacturing **DIVISION:** ------------- SH Structural Heart **LOCATION:** ------------- Costa Rica > Alajuela : Parque Industrial, Zona Franca Coyol S.A Edificio #44B, Call0, Avendia 2 **ADDITIONAL LOCATIONS:** ------------------------- **WORK SHIFT:** --------------- Cr09Sal (Costa Rica) **TRAVEL:** ----------- Yes, 5 % of the Time **MEDICAL SURVEILLANCE:** ------------------------- Yes **SIGNIFICANT WORK ACTIVITIES:** -------------------------------- Work in a clean room environment