Jan 19, 2019
Responsibilities: Improves manufacturing processes, methods and controls for cost reduction, quality improvements and efficiency for both sustained and new products Prepares engineering change orders and coordinates the deployment of changes including training operation team members Improves manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance for both sustained and new products Coordinates the manufacturing launch of new products including establishing yield targets, run rates, training needs and evaluating results Develops, tests and cost justifies various tools and equipment recommended for manufacturing methods Performs product and process analysis for cost reduction, quality improvement and improved efficiency Utilizes tools associated with risk management (PFMEA/Hazard Analysis) to identify potential risks and the associated corrective actions Supports required equipment qualification/process validation Troubleshoots processes when defects occur. Determine root cause and implement effective containment and countermeasures. Dispositions non-conforming products and develop re-work procedures Communicates with customers regarding process improvements and production changes Represents manufacturing on cross functional teams Participates in Kaizens and drive improvement efforts Other duties as assigned Requirements: EDUCATIONAL: Bachelor’s degree in Engineering or related field required Advanced knowledge of manufacturing and assembly processes A minimum of 5-8 years of engineering experience in a Medical manufacturing environment Previous experience and the ability to direct, lead and mentor engineers with respect to company engineering procedures, new product introduction, manufacturing support and tooling Excellent verbal and written communication skills Fluency in English TECHNICAL: Previous experience with Class III Medical devices, FDA standards, ISO 13485 and GMP principles preferred Technical leadership experience managing engineering teams, budgets and resources throughout various design phases, development and implementation of a new products Experience working cross functionally with other disciplines including engineering, quality, planning and scheduling Ability to lead, train, and engage manufacturing team members to reach Cirtec’s quality standards Must be able to read blueprints and interpret technical specifications and illustrations Association with supporting documents including, ECN’s, process deviation, non-conformances, stop shipment notifications and all associated quality related documents Strong computer skills associated with MS Office suite, Minitab and SolidWorks a plus Experience associated with continuous improvement activities, including participations and/or facilitating Kaizen events using lean manufacturing principles The ability to understand a range of engineering functions and procedures A practical and logical approach to problem solving using lean six sigma concepts Interpersonal, presentation and communication skills Team working and people management skills The capacity to work well under pressure and take on new challenges Organizational and time management skills Project management skills and the ability to work to tight deadlines An awareness of health and safety issues Willingness to travel, if required TRAINING: In house on the job training as required to meet job requirements. Keep up with current industry technologies by attending training courses and conferences. PERFORMANCE: Decision Making and Problem Solving: Must be able to make clear and accurate decisions. Analytical Problem Solving: Must be able to use a systematic approach to solving problems by researching and evaluating alternative solutions. Interaction: Must be able to communicate well, both verbally and in writing, and work well in a team environment. Initiative: Able to function with minimum supervision Versatility: Able to respond to changing priorities with minimum disruption. Leadership: Must be able to lead discussions and meetings with customers and staff related to job role.
South Bay, CA, USA