Project Engineer - Manufacturing Device Engineering Job - Stryker (Lakeland, FL) in Lakeland, Florida For Sale
Type: Labor, For Sale - Private.
Requisition ID: xxxx4BR 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 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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