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Manufacturing Engineer - Medical Device/SIX SIGMA/FEMA 80-110 K/yr

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Posted: 9 Oct 2009
Apply Deadline: 6 Jan 2010
Location: Spencer, IN, USA
IMMEDIATE OPPORTUNITY in Southern Indiana for twelve Senior Manufacturing Engineers to work with a Worldwide Manufacturer of Medical Device Equipment. These are permanent positions.

Responsibilities:

-> Develop and implement manufacturing business improvement projects and processes for disposable medical devices
-> Support teams to make improvements to existing devices and manufacturing processes. Lead complex projects independently with minimal supervision
-> Perform Six Sigma (Problem Solving and Process Improvement) and Lean tools to develop project opportunities to gain rates of improvement from manufacturing lines.
-> Utilize Design of Experiments to optimize processes
-> Write and perform process validations (IQ, OQ, PQ, PPQ) and validate methods for inspection for verification and process controls. Interface directly with assemblers, production supervisors, leads, engineers and management daily

Requirements:

-> BSME (Bachelor of Science, Mechanical Engineering), MET, or related Engineering Degree Problem Solving and Process Improvement Methodologies (e.g. 6 Sigma), and managing improvements through CAPA
-> a minimum Seven (7) years medical device experience in a process/manufacturing engineering role previous experience in the areas of Design for Manufacturing (DFM), Lean Manufacturing, and Process Control Concepts, Design of Experiments (DOE), Software Validation and product/process Failure Mode and Effects Analysis (FMEA)
-> Must have excellent mechanical aptitude, communication, project management and interpersonal skills Experience with CAD Software (Solid Works & AutoCAD)
-> Must be experienced in MS word, Excel and Project

Benefits:

-> Excellent Salary and Benefits Package
-> Relocation available for qualified candidates
Questions you will be asked:

• Required BSME (Bachelor of Science, Mechanical Engineering), MET, or related Engineering Degree. When and where did you graduate? MET preferred. Any additional education or certification? Describe.

• Describe your minimum Seven (7) years strong medical device experience in a process-manufacturing engineering role. When and Where.

• Describe your knowledge and experience specifically with working with FDA and any other regulatory compliance requirements.

• What types of medical devices have you worked on, Class II or III preferred.

Related Words: senior manufacturing engineer, medical device, fema, six sigma, mechanical engineering, bsme, manufacturing engineer, mechanical engineer, mechanical engineering, bsme, quality assurance, quality, qa, qc, statistical process control, spc, total quality management, tqm, process analyst, inspection, iso, taquchi, sampling theory, six sigma, six-sigma, 6 sigma, 6-sigma, sigma black belt, sigma black belts, master black belts, six sigma, six-sigma, 6 sigma, 6-sigma, sigma black belt, sigma black belts, master black belts, black belt, master blackbelt, master blackbelts, design for manufacturing (dfm), lean manufacturing, process control concepts, design of experiments (doe), software validation, failure mode effects analysis (fmea), cad software (solid works & autocad), iso 14001, goi, bom, router, fmea

Contact Information:

Please mention Misco Jobs when applying to this position.
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