Position Description Designs and plans layout for such activities as machining, metal forming, plastics processing, welding and brazing, assembly, and materials handling. Adapts machine or equipment design to factory and production conditions. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to Engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensure compliance with company programs procedures and applicable quality system regulations and standards Position Responsibilities Develops expertise knowledge of all factors that make a process to support the response to highly technical questions and situations, to solve quality issues, to improve process, or to confirm reliability of products. Collaborates with technical experts, Design team, and other facilities for the process development of new devices. Supports equipment development efforts for new devices, and process improvements. These efforts may be the internal development of process equipment or coordination with an external equipment integration company. Supports process owners. This support might include daily support of production operations as well as leading reliability and yield improvement activities for new products while handed off to the process owners. Provides engineering support to the remote facilities, as required. Builds relationships with counterparts at the worldwide manufacturing facilities to support the virtual factory that has been established as well as Global Technology Teams. Supports worldwide standardization of processes and products. Incorporates Six Sigma and Lean Manufacturing tools to support the critical initiatives of improving quality, reducing scrap, increasing yield, meeting ship commitments, and driving down cycle-time through the development of new processes. Applies Lean Sigma methodology to new process development activities, and process enhancements. Full understanding of all process intricacies to provide engineering knowledge for troubleshooting and root cause analysis and corrective actions Works on complex problems where analysis of situations or data requires an evaluation of many tangible and intangible factors. Individual will be required at times to make complex technical recommendations on product quality and reliability to sustain business activities. Writes Process and Equipment Specifications when applicable. Supports Product Return organization in providing root cause analysis with process expertise to explain field failures caused by new process issues. Supports the coordination and guidance of integral analysis of the processes / technologies utilizing appropriate tools, acting supporting the technical expert. Complies with standardization of methods and processes with other sites. Collaborates with Technical Experts to implement new Product/ Process activities across the facilities following Technology Roadmaps and Design Engineering activities. Determines and puts in place Parameter Monitoring to understand the health and performance of the process. Performs other position related duties as assigned. Quality Responsibilities Reports any observed or informed process and/or product non-conformities to the Supervisor. Finds resolution of Quality Situations at the area of responsibility. Reports any complaint regarding a Medtronic product to the Supervisor. Complies with all the requirements in the operational procedures at the area of responsibility in order to meet the requirements of all applicable Quality System regulations (e.g.: FDA Part 820 Quality System Regulation, ISO 13485 Quality Standard, R-PAL (Japanese QSR's). EHS Responsibilities Acknowledge and maintain commitment with the EHS Policy. Participate in the development of EHS improvement projects. Participate actively in the EHS programs to achieve the objectives and targets defined for the area. Engineers in Projects: Ensure that the EHS considerations, legal and corporate requirements and efficiency indicators are included in new project design and project evaluation in order to maximize the cost/benefit ratio and minimize the EHS impacts and risks. Ensure that EHS performance indicators are included in the selection process of contractors. Evaluate and re-evaluate periodically the EHS performance of contractors and sub-contractors. Supervise that contractors perform their job in accordance to the EHS requirements in order to reduce, minimize or prevent EHS impacts and risks. Maintain current knowledge of the potential EHS aspects and risks of new projects Minimum Education Bachelor Degree Basic Qualifications Background Educational: Applied or Natural Science, Engineering or Science of Engineering or field related to previously mentioned background. Experience: o Senior Level: 5 Years with Bachelors or 3 Years with Masters o Time on Engineering Internship accounts as is. Exposure to engineering and manufacturing environment Project Management Experience/Desired PMP Certified 3 years of experience managing New Product Introduction (NPI) for Medical Devices or FDA Regulated Industry High Proficient utilizing Microsoft MS Project Skills Analytical Thinking Problem Solving Interpersonal Relations Quality and Results Oriented Computer Literate Fluency speaking and writing in English and Spanish Desired/ Preferred Qualifications Background Experience in medical device, pharmaceutical, or electronic industry Skills Teamwork Communications Continues Improvement Project Management Root Cause Analysis Technical Writing and Composition Working Conditions Mental Components: Capacity to calculate, classify, compare, coordinate, copy, edit, evaluate, interview, instruct, read, observe, organize, plan, compile, select, request and document. Physical Components: Light work requiring physical effort, in addition, requires communication skills, capability to move from one place to another, visual discrimination and tolerance to the use of personal protection equipment. Environmental Work is performed in building's interior with normal temperature, good illumination, air condition, clean environment and minimum risk SDL2017
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