This position is responsible for investigating, planning, and implementing the more complex improvements in products and manufacturing processes that directly effects safety, quality, and productivity with the end result of producing a better quality product more efficiently. May at times be involved with leading projects requiring engineering team effort or a multi-discipline team effort. Assigns, delegates and assists in engineering related duties or projects to lower level engineers. 1. Work within a cross-functional team comprised of full-time R&D, Manufacturing Engineering and Quality Engineering resources, utilizing a structured new product development process to bring new medical devices to market, in compliance with QSR and ISO regulations. 2. Coordinate closely with other Manufacturing functional groups (Operations, Planning, Purchasing, Supply Chain, Facilities, etc.) 3. Maintain and follow proper ISO procedures and GMP requirements 4. Plan and implement specified projects to be completed including organizing and leading members of various sections, planning and scheduling, coordinating resources (personnel, materials, time, money, suppliers), preparing proper documentation, etc. 5. Provide technical expertise in the design, fabrication, development, installation and qualification of equipment that may include feasibility studies and/or proper documentation for justification of project and training to ensure proper operation of equipment. 6. Provide technical assistance and leadership in the planning and implementation of projects to develop, install, and qualify new processes for manufacturing new products or improving existing processes. 7. Research and implement cost reduction projects. 8. Monitor and control programs, identify issues and ensure they are resolved in a timely manner. 9. Gathering, tracking, and analyzing production data for meetings, business plan, etc. (yields/output/efficiencies). 10. Plan work schedules, expenditures, attend meetings, and prepare monthly reports are required. 11. Perform other job related duties as assigned
1. 6-8 years of increasing responsibility as an Engineer. 2. Experience in a manufacturing environment for designing, specifying, fabricating, assembling, and debugging machinery and manufacturing processes. 3. Ability to create and work from engineering drawings 4. Excellent analytical and problem solving skills 5. Thorough knowledge of statistical techniques, engineering drafting and personal computer knowledge 6. Excellent communication skills both verbal and written 7. Ability to lead project work 8. Thorough knowledge of electronic equipment and tools in laboratory testing, inspection system, hydraulics, pneumatics, and electrical circuits. 9. Knowledge of GMP/FDA regulations 10. Position exists in an office environment; however, does require gowning procedures to enter controlled environments. Occasional travel is required. 11. Should have good attendance record and good performance evaluations, and no disciplinary actions during the past twelve months 12. Should have good prior safety record and maintain safety record CONTACT: Chad Crow [Click Here to Email Your Resumé] 610-771-1086