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Manufacturing Engineer II

Company Name:
Thoratec Corporation
Thoratec Corporation has an opening for a Manufacturing Engineer II available at our office in Ann Arbor, Michigan.
JOB DUTIES: Troubleshoot and identify root cause on product failures and fixtures. Develop and validate manufacturing processes, including equipment identification, design, installation and validation for electro/mechanical assemblies. Design product assembly drawings, bill of materials, and component drawings in an ISO-9001/FDA GMP design and document control environment. Write useful fabrication procedures, QA procedures, and process control documents. Develop manufacturing process flow diagrams and process validation procedures. Evaluate process capability and identify needs for improvement. Collect and analyze in-process data to determine areas for process improvement. Provide technical support to manufacturing and QA to improve productivity and reduce costs. Work with R&D group to transfer new products into manufacturing. Provide input and support to Regulatory Affairs for FDA submission and to resolve customer concerns.
REQUIREMENTS: Bachelor's degree in Bioengineering, Biomedical Engineering Mechanical Engineering, or related field of study and 3 years experience in job offered or bio-engineering related occupation. Experience must include: 1. Process development, improvement and validation related to manufacturing electro-mechanical medical devices; 2. Fabrication, assembly and quality engineering for medical device products; 3. Regulatory standards for medical devices (IEC, ISO, FDA); 4. Statistical methods used in manufacturing (control charting, process capability, hypothesis testing, gauge R&R, design of experiments); 5. designing, specifying, fabricating, assembling, validating, debugging heart pump machinery / product and manufacturing processes; 6. creating and working on heart pumps from engineering drawings and/or specs of bio-engineering discipline; 7. statistical techniques/methods regarding heart pumps; 8. electronic/chemical equipment and tools in laboratory testing of heart pumps; 9. validating new pieces of equipment, test methods, writing and revising standard operating procedures for heart pumps; 10. improving manufacturing processes for heart pump systems; 11. performing NCMR investigations, designing manufacturing fixtures.
TO APPLY: Submit resume at www.thoratec.com/careers. Must reference Job # 6572.16.

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