Manassas Area , VA , United States
Support new product development or existing product line extensions / modifications by ensuring new products or manufacturing processes are designed to facilitate ease of manufacturing to produce quality, cost effective products with optimized yields.
Provide innovative and successful processes and equipment to meet project schedules and budget targets. Other responsibilities include * Evaluate and challenge product designs for manufacturability. * Participate with Product Development during the pilot manufacturing activities. * Develop work center layouts, estimate production times, staffing requirements and related costs. * Establish preliminary BOMs and routers for input into the ERP system. * Evaluate existing product flow, equipment and processes, investigate and identify new technology developments for ongoing improvements, including automation improvements, machine upgrades, and other technical improvements to drive process improvements to enhance quality, safety, customer satisfaction, production standards, and cost efficiencies. * Oversee production, installation, operation, maintenance, repair, and development of new, modified and/or existing equipment and fixtures * Develop project budgets, schedules, timetables, and capital equipment justification as needed * Define and generate all required documentation (IQ, OQ, PQ) for validation of equipment and processes used to manufacture products. Develop all manufacturing work instructions and procedures. * Maintain process documentation, bills of materials, drawings, procedures, routers, validation plans, protocols, and reports * Demonstrated hands-on process validation experience, including writing and executing protocols and reports (IQ, OQ, PQ)
* Good working knowledge of medical device manufacturing requirements and FDA QSRs and ISO compliance guidelines * Minimum 4 years manufacturing experience preferably medical device manufacturing * Devising and applying Lean Manufacturing principles and DFM * Automation design experience including PLC, pneumatic and hydraulics components and systems
• EDUCATION: BS degree in Manufacturing or Mechanical Engineering or related engineering field