MAIN PURPOSE OF ROLEThe manufacturing technician position supports the development and implementation of optimal, cost-effective manufacturing processes and methods in accordance with product specifications and quality standards; recommends and implements improvements to production processes, methods and controls; supports the activities related to instalation and validation of production lines as well as the lifecycle managment of equipments.**MAIN RESPONSIBILITIES**:- Daily support to the manufacturing activities in order to meet established goals for safety, quality, cost and production.- Maintains systems that support the monitoring of key performance indicators such as yield, per operators, reject parettos, etc. If indicators show an adverse trend, works with the functional team to plan and implement appropiate changes.- Lead yield/productivity analysis & improvement plans. Analyzes defective material to identify probable cause.- Executes installation/validation activities for new or existent production lines, meeting regulatory requirements.- Supports on the identification, selection and purchasing equipment/fixtures according to production requirements.- Keeps equipment operational by coordinating calibration, maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service when needed.- Able to interpret product requirements and specifications. Understands potential risks related to product malfunctions.- Has clear criteria of conforming/ non conforming product and the test methods used for verifying conformance.- Drives/executes change requets process within the area as required. Supports DL's training process. - Work in a cross functional team environment.- Paticipates in the identification and investigation of Non-conforming products. Uses Root cause problem solving techniques to identify and eliminate causes- Serves as a resource in the training of new team members. Mentors team members by sharing technical expertise and providing feedback and guidance.- May lead a project team, determining goals and objectives for the projects. May support/lead CIP improvement projects.QUALIFICATIONSEducationHigh school degree. Cursing an Engineering related career (at least 30% credits completed), Industrial, Electronics, Electromechanical, Electromedicine or otherengineering related fields.Experience/Background- 4+ years of experience in similar roles.- High school degree. Cursing an Engineering related career (at least 30% credits completed), Industrial, Electronics, Electromechanical, Electromedicine or otherengineering related fields- This position is to work in support areas for example: (Warehouse, solution preparation, Steam Sterilization, Laundry y Material Handler).- Demonstrated knowledge/expertise in a specific technical/Engineering area.- 80% of credits completed in an engineering related career would be considered equivalent to 4 years of experience- Capable to perform data analysis and data collection in excel or other software.- Strong computer software knowledge (Microsoft Word, Excel, Power Point).- Capable to support investigations using root cause problem solving methodologies.- Willing to travel.- Basic English level.- Knowledge of regulations associated to medical devices manufacturing for example FDA, GMP and ISO guidelines.- Generate models and/or scenarios for Direct Labor Headcount and equipment requirements that support the demand changes.- Desired experience in SAP.- This position is to work in support areas for example: (Warehouse, solution preparation, Steam Sterilization, Laundry y Material Handler).Preferred Qualifications & Education- 5+ years in a Medical Device Manufacturing or similar environment is preferred- Intermediate to advance level of English is a plus- Knowledge of regulations associated to medical devices manufacturing for example FDA, GMP and ISO guidelines.- Desired experience in validations execution- Procedures Change process experience is considered as a plus (Doc Change).
