The Opportunity This position works out of our Alajuela, Coyol location in the Vascular division that provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease.What You'll Do Initiates and completes technical activities leading to new or improved products or process, for current programs, next generation programs and to meet strategic goals and objectives of the company.
Prepares reports, publishes, and makes presentations to communicate findings.Analyzes and solves problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a major breakthrough in technology.Understands engineering principles theories, concepts, practices and techniques.
Develops knowledge in a field to become a recognized leader or authority in an area of technical specialization and applies this knowledge in leadership roles in the company.Incorporates business policies and procedures into task completion.
Understands the business needs of the company, and has knowledge of the customer needs of our business.
Understands the business cycle and foresight of emerging technologies trends.Interacts cross functionally and with internal and external customers.
Serves as a consultant for engineering or scientific interpretations and advice on significant matters.
Acts as a spokesperson to customers on business unit current and future capabilities.Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel.Influences middle management and another functional areas on technical or business solutions.Participate or lead Investigations, CAPA/Divisional CAPA and problem solving.Create, measure, challenge and Improve Product and Process documentation according Quality Management System.Active contribution to understand, connect and improve key process indicatorsManage part of the department budget to keep it under the Annual plan.Prepares product and process reports by collecting, analyzing, and summarizing information and trends.Performs installation/validation activities for new or existent production lines, meeting regulatory requirements.
That includes equipment, process, product and test method validations.Identifies, selects, and purchases equipment/fixtures according to production requirements, due to obsolescence, redundancy or line capacity expansion.
Has direct relation with vendors to define equipment suitability.Keeps equipment operational by coordinating calibration, maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service when needed.Assures that production lines output meet the specifications of the product.
Has clear criteria of conforming/non conforming product and the test methods used for verifying conformance.Maintains manufacturing systems such as SAP routers and BOM's current.Maintains procedures current and compliant to regulations.
Ensures practices at the manufacturing floor adhere to them.May supervise and provide technical assistance to non-exempt personnel, being accountable for their correct training and performance management.Assignments are expressed in the form of tasks and objectives; generally, makes day-to-day decisions within established guidelines regarding work processes or schedules in order to achieve the program objectives established by senior management; consequences of erroneous decisions would normally result in serious d lays to assigned projects or operations with substantial expenditure of time, human resources, and funds, without jeopardizing future business activity.Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.Monitors daily work operations and provides direction and guidance to lower-level supervisors, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.Monitors compliance with company policies and proceduresShift: Admin (Monday – Friday from 8:00 am to 5:00 pm)On-Site positionRequired QualificationsBachelor's degree in engineering or related STEM field5 - 7 years of related experienceExperience leading a team toward departmental goals; Safety, Quality, Delivery and Cost.Demonstrated understanding of how division and site strategy and objectives connect to day to day activity.Knowledge of Statistical techniques (DOE, SPC) is required.Advanced commands of EnglishPreferred QualificationsDesired experience in validation plans for medical industry products and processes and root cause problem solving methodologies.Knowledge of FDA, GMP and ISO guidelines.Operations experience desirable.
Detailed understanding of all operational metrics, such as: Units per hour (UPH), units per person per hour (UPPH), PFM, on time in full (OTIF), master production schedule performance (MPSP), manufacturing schedule performance (MSP), and cycle time required.
Particularly how you can influence these metrics in the engineering group lead role.Working knowledge of operational excellence.
Understanding of the difference between leading and lagging metrics.
Understanding of lean and six sigma principles – greenbelt certification desirable.
Project management experience and experience managing a project budget desirable.
