Kforce has a client that is seeking a Mid-Sr Catheter Manufacturing Engineer in Carlsbad, CA. Responsibilities: * Create and implement new manufacturing processes for new and current disposable medical devices * Work with suppliers around the world to understand and define their manufacturing process, equipment, tools/fixture to ensure quality products are being delivered * Perform characterization, Design of Experiments (DoE), and write/perform validation/verification of processes/inspection methods for manufacturing (IQ, OQ, PQ) * Create manufacturing documentation including work instructions, forms, BOMs, routers, FMEAs, DMR, and DHF documents, etc. * Support production on both sustaining activities and new products development from line setup through commercialization * Support production and own NCR, CAPA, and/or investigations * Innovate, design, and develop processes, procedures, tooling and/or automation * Train and provide guidance to manufacturing personnel and product technicians * Drive functional excellence initiatives for product/process and technical development * Other duties as assigned* Bachelor's degree in Engineering required, preferably Mechanical or Biomedical * 3+ years of medical device experience in process/manufacturing engineering role * Experience in Design for Manufacturing (DFM), Lean Manufacturing, Design of Experiments (DoE), technology/process transfer experience, product/process failure mode and effects analysis (FMEA), and problem-solving methodologies * Experience in a regulated environment; Preferably medical device * Understanding of medical device design controls / quality systems and product development processes * Solid knowledge of FDA regulations and interpretation of FDA regulations, guidelines and policy statements * CAD software ex. Solidworks * Excellent verbal/written communication skills * Ability to organize, records, and implement procedures