Alajuela, CRI
1 day ago
Principal TPM Operations Engineer
**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 Eletrophysiology Division. In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. As the Principal TPM Operation Engineer, you will support product transfers from Abbott sites to Third Party Manufacturers (TPMs), monitor and escalate supplier performance, and mitigate risk associated with new and existing TPMs globally. The role is responsible for operational/technical oversight of key TPMs with specific focus on fostering collaboration and continuous improvement to ensure the highest level of performance in all parts of the business. **What You’ll Do** + Operates within the TPM organizational goals and objectives, measures performance, and implements corrective actions when necessary. Provides guidance on root cause analysis. + Executes the organizational objectives and programs to reduce the total acquisition costs (product/component cost glide paths). Develops and implements consistent performance metrics for TPMs. + Supports product transfers from Abbott to TPMs by assuming responsibility as the manufacturing technical lead. Duties will include acquiring deep knowledge of the current manufacturing process, supporting the transfer or purchase of new equipment, transferring knowledge and process & validation documents to TPMs, ensuring raw material supply chain is established for TPMs and ensuring successful timely completion of project transfer milestones and ramp plan. + Responsible for initiating/facilitating/coordinating new and current product/component designs and design changes to achieve improved quality and cost. Provide the leadership of identifying and developing reliable and cost-effective manufacturing processes for all new and existing products/components manufactured by TPMs. + Third Party management – Facilitate strategic process changes with cross-functional teams for supplier management and material risk mitigation. Project coordinator for assigned TPM impacted programs such as product transfers, continuous improvement initiatives, material changes, validation of new manufacturing process, etc., providing oversight and guidance to Supply Chain, Quality, and Regulatory functions to ensure uninterrupted product/component supply. Ensures approved projects are within budget. + Become knowledgeable of TPM business, systems and processes through close work with Marketing, Quality Assurance, Engineering, R&D, Purchasing, Regulatory, Legal, Supply Chain, and Logistics. Ensure TPM governance is operated within to ensure clear roles and responsibilities, review process and metrics. Executed agreed strategies to address TPM performance issues. + Evaluation and identification of technical manufacturing capabilities of current and future TPMs. Leads activities to close gaps where applicable. Provides subject matter expertise during due diligence assessments. + Supports global supply chain, operations, and engineering to ensure commercial needs and requirements are met through effective and efficient TPM strategies. Leads internal project teams to successfully manage new manufacturing site start-ups. + Accountable to establish and maintain effective cross-functional communication and working relationships between Abbott and Supplier’s Quality, Supply Chain, Finance, R&D, Regulatory, etc., functions. Coordinates internal and external resources to address issues and ensure supply. + Responsible for compliance with applicable Corporate and Division policies and procedures. Evaluates cost/benefit of various financial scenarios and makes recommendations to management. Knowledge of regulatory and compliance requirements linked to manufacturing. **Required Qualifications** + Bachelor’s Degree in Engineering, Supply Chain Management, or other technical field of study. + 7+ years of experience on manufacturing engineering roles, preferably within the medical device industry. + At least 3-5 years of experience leading projects with Third Party Manufacturers (TPMs). + Experience working across functional areas and processes and understanding of the various operational disciplines (i.e., Engineering, Manufacturing, Logistics, Purchasing, Supply Chain). + 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. + Experience in project management involving coordination of cross functional teams. + Statistical techniques knowledge (DOE, SPC) is required. PE license is a plus. + Computer software knowledge (Microsoft Word, Excel, Power Point). + Willing to travel. Travel estimated to be up to 20%, with most travel occurring within Costa Rica. + Fully Bilingual (English and Spanish) required. **Preferred Qualifications** + 5 years prior experience in medical devices manufacturing. + Performance management experience preferred. **SHIFT ADMIN** (Monday to Friday 8:00 am to 5:00 pm) Works **100% on site** . 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 , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
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