Technical NPI Manager
hace 1 mes
The Opportunity
This position plays a critical role in the Electrophysiology business unit at Abbott, advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation. The successful candidate will have the opportunity to work in a dynamic environment, collaborating with cross-functional teams to bring new products to market.
Job Summary
The Technical NPI Manager will be responsible for planning, installing, validating, and starting up new products in the Costa Rica site. This role will oversee the integration of new products into the Costa Rica Quality System and ERP system, ensuring seamless execution and control to meet established goals and timelines.
Key Responsibilities
- Oversee and ensure proper 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 to the CR Quality System.
- Ensure integration of new products to the CR ERP system and to the processes/systems established in the different functional areas.
- Ensure technical knowledge and historical data transfer of new products manufacturing processes and assemblies/subassemblies performance.
- Oversee and ensure proper planning and execution to meet new products ramp-up goals.
- Assure execution of equipment, process, and product validations as per the Master Validation Plan and project schedules.
- Support fulfillment of requirements for regulatory submissions and regulatory bodies on-site audits.
Requirements
- Bachelor's degree in engineering.
- 8+ years of manufacturing/process development experience, with a minimum of 6 years of people management (directing or supporting role is acceptable).
- Advance knowledge of medical devices regulations, including FDA's 21 CFR Part 820 (Quality System Regulation) and 21 CFR Part 11 (Electronic Records; Electronic Signatures) and ISO 13485.
- Plan, execute, and control a project.
- Report assigned activities' status and results to executive management.
- Conduct a significant amount of planning activities for self and others.
- Coordinate and direct activities involving participation of other departments and teams from other sites; guide and delegate to subordinates and project team members.
- Function in a controlled environment regulated by FDA GMPs and ISO 13485.
- Define department strategic objectives.
- Develop annual department or projects budget and manage/report variances.
- Interact with diverse cultures and personalities.
- Fully bilingual (English and Spanish).
- Willing to travel.
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