Technical NPI Manager

hace 4 semanas

Alajuela, Alajuela, Costa Rica Abbott A tiempo completo
The Opportunity

This position is part of our Electrophysiology business unit, which is 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.

The Technical New Product Introduction Manager

This role will be responsible for planning, installing, validating, and starting up specific products introduced into the Costa Rica site. Operations and Engineering Manager roles will be performed throughout the duration of each new product introduction. Essential functions for this position will be specified per period of time, taking into account the change in the role once the transfer of new product(s) is completed and the production ramp-up starts. Additional functions may be related to volume moves between sites, which may include capacity expansion projects or moves to other sites.

Key Responsibilities
  1. Oversee and ensure proper project definition, planning, execution, and control to meet established goals and timelines. Ensure deviations to the project schedules, quality, or costs are investigated and properly followed up on.
  2. Coordinate new product introduction resources within the Costa Rica organization.
  3. Ensure integration of the new product to the CR Quality System.
  4. Ensure integration of the new product to the CR ERP system and to the processes/systems established in the different functional areas.
  5. Ensure technical knowledge and historical data transfer of new product manufacturing processes and assemblies/subassemblies performance.
  6. Oversee and ensure proper planning and execution to meet new product ramp-up goals.
  7. 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.
  8. Support fulfillment of requirements for regulatory submissions and regulatory bodies on-site audits.
  9. Oversee and ensure proper production execution, control of the planning scheduling programs to meet established volume plans/forecasts and to balance the level of manpower and equipment requirements. Ensure deviations to the production schedule are investigated and properly followed up on.
  10. Direct production activities in accordance with established priorities to maintain optimum in-process inventory levels.
  11. Ensure product conformance to quality standards.
  12. Oversee manufacturing supervision and support technical projects related to yield improvements, cost reduction, process control, and others.
  13. Oversee supervision of operations support areas such as process engineering, equipment maintenance, industrial engineering, and continuous improvement.
  14. Maintain operations KPIs within the established goals.
  15. Oversee and ensure proper project definition, planning, execution, and control to meet established goals and timelines for volume moves projects.
  16. Ensure Quality Systems requirements are met.
  17. Assure all project deliverables are met and otherwise justified.
Requirements
  • Bachelor's degree in engineering.
  • Experience: 8+ years manufacturing/process development experience, with minimum 6 years people management (directing or supporting role is acceptable).
  • Has advanced knowledge of medical devices regulations, such as 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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