Hi all -
Below are three manufacturing engineer job openings available at a Bay Area medical device company from a recruiter I've worked with. If any of these positions might be a fit for you, contact
Harris Recruiting LLC
Tammy Harris / Placement Director
Office: 205-421-1772
Fax: 205-629-3068
Cell: 205-616-7946
harrisrecruiting@windstream.net
Hope this helps!
POSITION 1: Senior Manufacturing Engineer (defined term)
SPECIFIC RESPONSIBILITIES:
Leads and/or participates in 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. Plans, schedules, conducts or coordinates detailed phases of the engineering work in a part of a major project or in a total project of moderate scope. Performs 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. Performs 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. Interfaces with vendors and other outside specialists. Participates in Quality Circle (REFINE) activities. Audits, investigates, tests, and evaluates external process technologies. Performs responsibilities required by the Quality System and other duties as assigned or requested.
REQUIREMENTS:
B.S. in Engineering (mechanical/electrical preferred) plus minimum 5-8 years of engineering experience in a manufacturing environment, minimum of 2 years experience in an FDA regulated manufacturing environment required. Or equivalent combination of education and experience. 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. Must have validation experience working with IQ, OQ, PQ. Strong troubleshooting skills working with process and equipment. Previous experience working with BSC Change Request system is highly preferred. Six Sigma skills are big plusses! Position is defined term and has an estimated duration of 2 years.
POSITION 2: Senior Manufacturing Engineer (defined term)
SPECIFIC RESPONSIBILITIES:
Leads and/or participates in 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. Plans, schedules, conducts or coordinates detailed phases of the engineering work in a part of a major project or in a total project of moderate scope. Performs 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. Performs 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. Interfaces with vendors and other outside specialists. Participates in Quality Circle (REFINE) activities. Audits, investigates, tests, and evaluates external process technologies. Performs responsibilities required by the Quality System and other duties as assigned or requested.
REQUIREMENTS:
B.S. in Engineering (mechanical/electrical preferred) plus minimum 5-8 years of engineering experience in a manufacturing environment, minimum of 2 years experience in an FDA regulated manufacturing environment required. Or equivalent combination of education and experience. 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. Must have validation experience working with IQ, OQ, PQ. Strong troubleshooting skills working with process and equipment. Previous experience working with BSC Change Request system is highly preferred. Six Sigma skills are big plusses! Position is defined term and has an estimated duration of 2 years.
POSITION 3: Manufacturing Engineer II (defined term)
SPECIFIC RESPONSIBILITIES:
Participate in project teams typically including one of the following: identifying and implementing process/product improvement alternatives to increase/optimize yield, efficiency, throughput, and/or performance; designing, performing, and documenting engineering test experiments to evaluate product/product performance; participating in Quality Circle (REFINE) activities; designing, developing, testing, and validating equipment, tools and fixtures; analyzing and interpreting process models and recommending process improvements; evaluate external process technologies and other activities of limited scope requiring knowledge of principles and techniques commonly employed in the specific narrow area of assignments. Interface with assemblers, production supervisors, and engineers in troubleshooting problems on the production floor. Coordinate with the appropriate suppliers and other external resources needed in developing and implementing process/product improvement plans. Act independently to implement and follow through. Participate in project planning and scheduling. Attend product-related meetings. Perform responsibilities required by the Quality System and other duties as assigned or requested.
REQUIREMENTS:
BS in Mechanical Engineering or Science or related degree with 2 years related experience, or MS with a minimum of 1 year experience, a minimum of 2 years prior engineering experience. Experience in manufacturing environment. Strong technical and organization skills and verbal communication skills. Knowledge of Good Manufacturing Practices. Knowledge of JIT a plus. Knowledge of materials and manufacturing processes helpful. Or, the equivalent combination of education/experience required to perform at this level. Six Sigma skills (training and/or certification) are a big plusses! Medical device experience highly preferred. This position is defined-term and has an estimated duration of 2 years.
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