The Senior Manufacturing Engineer will plan and conduct work supporting Imaging medical device development/manufacturing that require judgment on the independent evaluation, selection and substantial adaptation/modification of standard techniques, procedures, and criteria.
Engineering specialty involves the improvement of existing manufacturing processes interfacing with production and engineering groups in resolving problems encountered on the production floor.
Lead and/or participate on project teams coordinating the efforts of engineers, technicians and other professionals of various disciplines/departments to design, develop, and continuously improve product, equipment, and fixture processes.
Perform engineering work typically including one of the following: process/product improvements, test of materials, preparation of specifications, process study, evaluation of process models/process improvements, product design, development improvement of equipment, tools, fixtures, report preparation, and other activities of wide scope requiring broad knowledge of precedents in medical device design and development and good knowledge of principles and practices of related specialties.
Interface with vendors and other outside specialists. Audit, investigate, test, and evaluate external process technologies.
Apply Six Sigma skills to reduce cost and improve yields.
B.S. / M.S. in Mechanical, Electrical, Chemical, Materials or Industrial Engineering plus a minimum 5-8 years of engineering experience in a manufacturing environment with a minimum of 2 years experience in an FDA regulated manufacturing environment required. Or, equivalent combination of education and experience to perform at this level. Proven Lean/Six Sigma / DOE/ and Process Validation skills. Black or green belt preferred. Proficiency with Medical Device development life cycles and manufacturing processes and technologies preferred. Knowledge of FDA regulations preferred. Knowledge of JIT and/or Lean Flow Manufacturing helpful. Knowledge of materials/ plastics helpful.