PURPOSE OF JOB Collaborate with Operations to implement improvement opportunities in the process to ensure production goals are achieved. Collaborate with the transfer of products to manufacture and ensure a high degree of process capability. Validate process changes with documentation and necessary approvals. Responsibilities Supports Production area in troubleshooting process and deliver timely solutions for product development. Responds quickly to the occurrence of defects and unplanned production down-times due to equipment failures, process issues. Solves related problems to resume production. Leads a team to investigate the root causes of process problems and implements corrective actions. Develops procedures to ensure product quality / process capability and reduces process variability ensuring consistency in Mfg. execution. Reviews/Develops procedures to ensure accuracy and upgrades required by change orders in the documentation. Works with Production to develop production processes, standard operating procedures, and drawings. Has relationships with R&D, sourcing, and supplier engineering to pursue new development projects as well as seek cost improvements on existing products. Attends daily shift meetings and communicates by providing updates with various departments. Performs nonconformance and corrective actions investigation from root cause all the way to effectiveness. Responsible for creating, routing and execution of all engineering reports, including all the validation phases as of engineering studies, process development, installation, operational and performance qualifications. Informs project status to all levels of organization, including performance, cost, and schedule updates. Utilizes DMAIC, OpEx, and mistake proof methodologies in the development of manufacturing processes to implement processes that are 'born lean and capable'. Facilitates ease of manufacturing to produce quality, cost effective products with optimized yields. Evaluates/Changes existing product flow, investigates and identifies new technology developments including automation-based solutions, and other technical improvements to drive process improvements to enhance quality, safety, customer satisfaction, production standards, and cost efficiencies. Develops budget and schedule for projects and manages them. Monitors daily/weekly/monthly product key metric trends and develops action plans as required (i.e. scrap, equipment downtime). Determine parts and tools needed, and its controls in order to achieve manufacturing goals and reduce costs. Collaborate with the development and transfer of products. Manage the installation and proper performance of new processes and equipment. Conduct verification and validation of new processes and modifications to ensure process capability. Other functions might be assigned based on company's needs. REQUIREMENTS EDUCATION: Bachelor's degree in Engineering, Manufacturing or a related field. Bilingual: Spanish - English (B2 level minimum) Postgraduate degree preferred EXPERIENCE: Minimum 7 years in a medical device manufacturing environment. Validation execution experience, process characterization (IQ, OQ, PQ) Experience with GMPs and ISO 13485 (preferred) Lean Six Sigma experience (preferred) Experience working with Catheters and Guide wires (preferred) Desirable transfer experience Powered by JazzHR
