Medical Manufacturing Engineer

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    "requisitionDescription": "<div><div><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">DUTIES AND RESPONSABILITIES</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;2.1 &nbsp;Determine Processing Requirements to produce cost effective conforming product.&nbsp;</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;2.2 &nbsp;Create, edit, and support documentation efforts for process development and continual improvements (i.e. Work Instructions, PFMEAs Process Flow, etc.) as needed.</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;2.3 &nbsp;Create, edit, and support quality on dimensional inspections.&nbsp;</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;2.4 &nbsp;Determine, document methodology for inspection specifications for setting up inspections, to include but not limited to, gage designs and prints, etc.&nbsp;</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;2.5 &nbsp;Receives requests from staff and reviews drawings for accuracy prior to release to the floor, including but not limited to, creating/updating Exalta blank and in-process prints.&nbsp;</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;2.6 &nbsp;Evaluates data to identify deviation from specifications to communicate to management.&nbsp;</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;2.7 &nbsp;Develop manufacturing blueprints, routers, BOMs, and other supporting documents.&nbsp;</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;2.8 &nbsp;Create validation protocols based on Master Validation Plan and customer specific procedures execute approved validations protocols and create validation summary reports.</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;2.9 &nbsp;Support production flow of prototypes, verification runs, etc. Support initial production runs and support Design for Manufacturability reviews for customer feedback.</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;2.10 Design and develop tools, fixtures for standardization of processes for improved &nbsp;manufacturability and throughput.</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;2.11 Review and conduct root cause analysis on deviations that were identified during validation activities and resolve the deviated condition or justify why the deviation is acceptable.</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;2.12 Understand and work toward Engineering objectives, cost containment, process development, root cause analysis, data analysis, etc.&nbsp;</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;2.13 Evaluate and improve manufacturing processes by applying knowledge of product design, fabrication, assembly, tooling and materials.&nbsp;</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;2.14 Manage projects and flow of the design transfer process through prototyping and into production including but not limited to reporting status, timeline development, etc.&nbsp;</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp;</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">KEY SKILLS, KNOWLEDGE, AND COMPETENCIES</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;3.1 &nbsp;General Knowledge and understanding of IS0 13485 and FDA 21 CFR 820 as it pertains to process, inspection, validation, verification, design control, and documentation, etc.&nbsp;</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;3.2 &nbsp;At least 3-5 years of experience in Product Development, Quality Control, Quality Assurance and/or Manufacturing Process position at a Medical Device manufacturer preferred. Design and Machining experience a plus.&nbsp;</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;3.3 SolidWorks software knowledge and experience a must.&nbsp;</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;3.4 Minitab analysis knowledge a must.&nbsp;</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;3.5 Ability to read blueprints, customer/internal specifications, and procedures</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;3.6 &nbsp;Detailed knowledge of using precision measuring instruments. The instruments should include, but not be limited to calipers, ID and OD micrometers, depth gages, indicators, and plug and tread Go/ No Go gauges.</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;3.7 Detail Oriented as shown by documented measurement accuracy, to include but not limited to print reviews, document reviews, and organizational skills.</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;3.8 Proficient English communication skills- reading, writing, and speaking- as it relates to the job, Spanish a plus. Provide verbal instruction and training to the other personnel and operators on implementation of processes, inspection methods, performing &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;validations, and proper documentation.&nbsp;</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;3.9 Skilled in basic math including but not limited to adding, subtracting, multiplication, division, and basic algebra for the purpose of calculating specifications and engineering calculations.</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;3.10 Skilled in adapting to a changing work environment, competing demands and ability to deal with frequent change, delays or unexpected events while maintaining timelines.&nbsp;</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;3.11 Skilled in adapting to a changing work environment, competing demands and ability to deal with frequent change, delays or unexpected events while maintaining timelines.&nbsp;</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;3.12 Skilled in working independently, following through with assignments with minimal direction. Leadership skills a must.&nbsp;</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;3.13 Reasoning skills including but not limited to to comparing, classifying, analyzing and coordinating- minimizing duplication of effort.&nbsp;</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;3.14 Evaluate and improve manufacturing processes by applying knowledge of product design, fabrication, assembly, tooling and materials.&nbsp;</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><br></span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">EDUCATION, CERTIFICATIONS, AND/OR LICENSES REQUIREMENTS:</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; B.S. in Mechanical Engineering, Manufacturing Engineering or equivalent</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><br></span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">PHYSICAL REQUIREMENTS:</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; Ability to lift up to 50 lbs. and operate material handling equipment safely</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\"><br></span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">PERSONAL PROTECTIVE EQUIPMENT REQUIREMENTS:</span></p><p><span style=\"font-size: 14px; font-family: arial, sans-serif;\">&nbsp; &nbsp; &nbsp; &nbsp; &nbsp;Safety glasses on the manufacturing floor.</span></p></div></div>\n",
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