Project Engineer - Manufacturing Device Engineering - Stryker (Lakeland, FL) in Lakeland, Florida For Sale
Type: Labor, For Sale - Private.
Requisition ID xxxx3BR Job Title Project Engineer - Manufacturing Device Engineering Division Global Quality & Ops Business Unit Sustainability Solutions Business Functions Engineering Business Sub-Functions Manufacturing Engineering Country United States State FL City Lakeland Shift 1st Job Description Responsible for sustainment and optimization of existing Surgical and Non Invasive Manufacturing Processes. Perform Line Extensions, Design Changes, and Process/quality improvements following design control, regulatory compliance and risk management requirements. Lead MDE/Engineering Technicians and Technical Writers as necessary. Interact with external departments as needed. ESSENTIAL DUTIES: -Improve/support existing processes using Kaizen, Green Belt, and Good Manufacturing Practices (GMP's) methodologies. -Accurately transfer design changed or line extended devices on to production floor. -Ability to effectively communicate and interact internally and externally with departments such as Quality, Operations, Regulatory Affairs, Mfg. Engineering, Customer Service, Marketing, Sales, as well as external customers and suppliers. -Ability to generate project plans and accurately execute project tasks. -Discuss progress and interim findings at periodic design/project review meetings. -Establishes/modifies test protocols specified by customer input, national and international standards, and regulatory requirements. -Directs and facilitates the testing of products to verify the ability to effectively clean, test and sterilize design change and line extended devices. -Perform Failure Analyses (FA's) and Improve Functionality/Performance of Surgical and Non-Invasive Medical Devices. -Implement Process Improvements and Machining Improvements on Production Lines. -Reduce Reject Rates and Optimize Manufacturing Processes. -Implement Safety Improvements on Production Lines. -Assist in the development of technical protocols and reports. -Knowledge of FDA requirements associated with the development of medical devices including Design Control and understanding the technical support required for regulatory submissions. -Performs other duties as directed or assigned. EDUCATION & QUALIFICATIONS: -BA or BS in Engineering/Science discipline or equivalent experience. -1 to 3 years of medical device, FDA or other regulated experience desired. -Effective writing and oral communications skills. -Proficient in project management principles. -Proficient in managing projects to effectively complete assignments and achieve desired outcomes. -Excellent organizational skills and ability to plan/prioritize activities. -Ability to work independently and with a team. -Strong verbal and written communication skills; ability to present issues, plans and objectives. -Ability to work in fast paced organization, meeting multiple deadlines and succeeding under pressure is a must. -Motivated, resourceful, ambitious, enthusiastic and attentive to detail. -Knowledge of FDA and ISO requirements. -High ethical standards, well organized. -Ability to interact with associates on all levels (production, management, executive, etc.). -Computer literate with a working knowledge of Microsoft Word and Excel required; Visio, AutoCAD, SolidWorks, Microsoft Project preferred. -Ability to meet deadlines, attention to detail and good problem solving skills. Percent Travel Required 0%
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