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Job: Sr. Manufacturing Engineer - Medical Device, Class Iii (300798) in San Clemente, CA

SANLINK SERVICES

posted on 11/17/2009

Summary

We are looking for a mid level to Sr level Manufacturing Engineer, Class III medical device experience preferreedPOSITION SUMMARY:Support Operations group through development and support of manufacturing equipment and processes in assembly of an implantable medical device.DUTIES & RESPONSIBILITIESSelect, develop, and validate manufacturing processes, equipment, and tooling for the electromechanical assembly of a medical device.Support production through efficient and effective identification and resolution of line issues.Identify and initiate process improvement projects that have meaningful impact on product quality and process yield.Interface with Design Engineers to provide timely feedback on proposed designs and influence organization to develop a strong design for manufacturability culture.Properly document activities in accordance with best engineering practices, company procedures, and regulatory requirements.Interface with external vendors to source high quality equipment and fixtures.Effectively train operators, technicians, and engineers on use of equipment and fixtures.POSITION QUALIFICATION REQUIREMENTS Bachelor of science degree in mechanical engineering and min 3 years of experience in medical or other high-reliability manufacturing environment, or equivalent combination of education and experience.CAD Mechanical design experience developing tooling and fixtures.Ability to read and interpret engineering drawings for the purpose of understanding equipment function and product design.Equipment knowledge and process experience with electromechanical assembly, such as welding, soldering, adhesive bonding, hermetic sealing, surface finishing, packaging, or sterilization.Experience with Statistical Process Control, Design of Experiments, Just in Time, and Lean manufacturing techniques.PC computer proficiency with MS Office..Ability to use precision measuring devices such as calipers, pin gauges, and optical comparators.Manual dexterity and hand-eye coordination to develop assembly processes for medical devices. Capability to use equipment such as microscopes, soldering irons, mechanical and electrical assembly tooling and fixtures, adhesive dispensers, tweezers, crimpers, cutters and hand tools. Some lifting to 30 pounds.Capability to work in a clean room environment and wear appropriate gowns, hair nets, and gloves.Good teamwork, communication and interpersonal skills. A demonstrated commitment to company values.POSITION PREFERENCESMedical Device manufacturing experience, including ISO and FDA requirements.Experience with planning and executing complex projects.Master's degree in Engineering discipline Strong process knowledge in manufacturing of electronic devicesLean Manufacturing, Six SigmaNote: Our client is located in Orange County, Southern California. Non-local and out of state candidates will be considered.