Manufacturing Engineer

Manufacturing Engineer Exercises technical leadership and analytical skills in the resolution of production issues. Demonstrates creativity in implementing process improvements and new manufacturing methods including the conception, design and implementation of new tools, fixtures, and software. Prepares technical reports, draft and executes process/software validations. This position would be responsible to closely work with design & mechanical engineers to provide necessary support by applying theory and principles of mechanical engineering to develop, assemble, modify, test and/or calibrate prototype products, machinery and test equipment under the direction of Manufacturing Engineering management staff. Duties and Responsibilities Review prototype, test instructions and schematics to ascertain test specifications, procedures, and objectives. Interpret engineering prototypes, test instructions, and schematics to identify, modify and plan requirements for fabrication, assembly, testing and test nature of technical problems. Actively participate on new product release teams from the earliest phases to assure that design for manufacturing concepts are employed and to facilitate a smooth transition from Engineering to Manufacturing. Owns the development of assembly processes for new products as well as the introduction of new methods into the assembly processes of current products and associated PFMEA's. Devise, fabricate and assemble new or modified assembly and test fixtures using appropriate machine shop and/or hand tools or software modules. Apply DOE and statistical tools to identify root cause(s) of yield loss and propose and implement corrective actions, make recommendations for changes in test fixtures or test methods by applying theory & principles of mechanical engineering. Maintain Work Instructions, BOM's, preventative maintenance schedules, and Routers. Record test procedures and results; write test reports using numerical and graphical data using Excel and Word. Confer with engineering staff and submit reports of test results to engineering department and recommend design or material changes. Actively participate in discussions related to changes in design, method of manufacture and assembly, and drafting techniques and procedures with staff and coordinate corrections. Document software specifications for review prior to development of software. Develop and release software in a controlled manner, ensure developmental software is not active prior to validation and release. Identify and resolve manufacturing errors expeditiously with attention to impact on safety/ergonomics, quality, cost and production schedules from software. Perform other work-related duties as requested, directed or assigned by management. Education and Experience BS in Mechanical, Manufacturing, or Biomedical Engineering required. MS in Mechanical or Biomedical Engineering preferred. Minimum of two years' experience. Preferred is prior experience in medical device industry and familiarity with

FDA CGMP

regulations. Proficiency in 3D Modeling required. Proficiency in LabVIEW programming preferred. Experience in systems design.