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Technical NPI Manager
hace 2 meses
The Opportunity
This position plays a critical role in the Electrophysiology business unit at Abbott, advancing the treatment of heart disease through innovative medical technologies. The Technical New Product Introduction Manager will be responsible for planning, installing, validating, and starting up new products at the Costa Rica site.
Key Responsibilities
- Oversee project definition, planning, execution, and control to meet established goals and timelines.
- Coordinate new product introduction resources within the Costa Rica organization.
- Ensure integration of new products with the CR Quality System and ERP system.
- Transfer technical knowledge and historical data of new products manufacturing processes and assemblies/subassemblies performance.
- Plan and execute new product ramp-up goals.
New Product Validation Period
- Assure execution of equipment, process, and product validations as per the Master Validation Plan and project schedules.
- Lead investigations to deviations and ensure impact to timelines are properly handled and followed up on.
New Product Sustaining Period
- Oversee production execution, control of planning scheduling programs to meet established volume plans/forecasts and balance manpower and equipment requirements.
- Direct production activities in accordance with established priorities to maintain optimum in-process inventory levels.
- Ensure product conformance to quality standards.
- Oversee manufacturing supervision and support technical projects related to yield improvements, cost reduction, process control, and others.
Requirements
- Bachelor's degree in engineering.
- 8+ years of manufacturing/process development experience, with a minimum of 6 years of people management experience.
- Advance knowledge of medical devices regulations, including FDA's 21 CFR Part 820 and ISO.
- Ability to plan, execute, and control projects, report status and results to executive management, and conduct planning activities for self and others.
- Fluency in English and Spanish, with the ability to interact with diverse cultures and personalities.
