Engineer, Sr Mfg - 100146 - Fremont, CA - 0300 – Fremont

Responsibilities:
The senior manufacturing engineer will plan and conduct work requiring judgment on the independent evaluation, selection and substantial adaptation/modification of standard techniques, procedures, and criteria. Devise new approaches to problems encountered. 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, fixture processes. Plan, schedule, conduct or coordinate detailed phases of the engineering work in a part of a major project or in a total project of moderate scope. Perform work which involves conventional engineering practice but may include a variety of complex features such a conflicting design requirements, unsuitability of standard materials, and difficult coordination requirement. 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. Participate in Quality Circle activities. Audit, investigate, test, and evaluate external process technologies. Perform responsibilities required by the Quality System and other duties as assigned or requested.


Qualifications:
B.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. 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 helpful.

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