The Opportunity This position works out of our Alajuela, Coyol location in the Electrophysiology business unit.
EP is advancing the treatment ofheart 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 will be responsible for the planning, installation, validation and start-up activities for specific product(s) introduced into Costa Rica Site.
Operations and Engineering Manager roles are performed throughout the duration of each new product introduction.
Essential functions for this position are specified per period of time taking into account the change on 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, this may be capacity expansion projects or moves to other sites.What You'll DoNew Product(s) Transfer PeriodOversee and ensure proper project definition, planning, execution and control to meet the established goals and timelines.
Ensure deviations to the projects schedules, quality or costs are investigated and properly followed up on.Coordinate new products introduction resources within the Costa Rica organization.Ensure integration of the new products to the CR Quality System.Ensure integration of the new products to the CR ERP system & to the processes / systems established in the different functional areas.Ensure technical knowledge and historical data transfer of new products manufacturing processes & assemblies / subassemblies performance.Oversee and ensure proper planning and execution to meet new products ramp up goals.New Product(s) Validation Period Assure execution of equipment, process and product validations as per the Master Validation Plan and project schedules.
Lead investigations to deviations & ensure impact to timelines are properly handled and followed up on.Support fulfillment of requirements for regulatory submissions and regulatory bodies on site audits.New Product(s) Sustaining PeriodOversee 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.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, costs reduction, process control, between others.Oversee supervision of operations support areas as process engineering, equipment maintenance, industrial engineering & continuous improvement.Maintain operations KPIs within the established goalsVolume Moves ProjectsOversee and ensure proper project definition, planning, execution and control to meet the established goals and timelines.Ensure Quality Systems requirements are met.Assure all project deliverables are met and otherwise justifiedBachelor's degree in engineeringExperience: 8+ years manufacturing/process development experience, with minimum 6 years people management (directing or supporting role is acceptable).Experience Details: Has advance knowledge of medical devices regulations: ie 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 projectReport assigned activities' status & results to executive management.Conduct a significant amount of planning activities for self and othersCoordinate and direct activities involving participation of other departments & teams from other sites; guide and delegate to subordinates and project team members.Function in a controlled environment regulated by FDA GMPs & 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.
