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Manufacturing Engineer

Westborough, MA

Order: 20553
Direct Hire
Job Purpose The Manufacturing Engineer will provide engineering support which includes: improving manufacturing efficiencies, ensuring quality disposable products are produced, and reducing manufacturing costs. The manufacturing engineer will work with all departments throughout the operation. Responsibilities • Analyze production processes and equipment and identify opportunities for quality improvement and cost reduction • Investigate and resolve technical problems related to materials, process and product • Develop and initiate production processes for new and existing products using knowledge of assembly techniques • Assist with analysis of product reliability information and perform periodic root cause analysis to identify quality or cost improvement opportunities • Review product materials and Bills of Materials and manage selection or modification of materials, joining methods and manufacturing processes • Review and create production documentation as required • Develop process validation protocols, perform testing, and evaluate results, using statistical techniques • Ensure compliance to Design Control requirements, CGMP, FDA, QSR, MDD and company policies • Participate in Material Review Board meetings and disposition of non-conforming material • Participate in the investigation and evaluation of product failures and complaints • Identify and implement corrective and preventative actions • Ensure documentation for manufacturing equipment is complete • Support preventative maintenance process of manufacturing equipment as assigned • Design and manufacture or coordinate manufacture of new, replacement or alternative jigs, fixtures or equipment • Perform periodic monitoring of manufacturing processes to ensure the manufacturing personnel are building to the proper drawings and process sheets • Work with other departments in the transition of product from R&D or other companies into Manufacturing. • Manufacturing process conceptualization and development and acquisition of equipment and fixtures • Create project plans utilizing Microsoft Project or equivalent and communicate project as appropriate for the assigned projects to capture and measure goals, assign responsibilities and manage timelines • Work closely with personnel in other departments to meet project goals Qualifications • Minimum of 4 years of experience in manufacturing engineering of medical devices composed of a variety of metals and plastics or equivalent experience; experience with plastics and endoscopes a plus • BS in mechanical engineering or other related discipline • Strong organizational skills including attention to detail and the ability to handle multiple projects • Excellent interpersonal and communication skills, oral and written, for interaction at all levels both within and outside the company to achieve goals and objectives • Knowledge and application of statistical methods strongly desired • Knowledge of FDA and MDD regulations preferred • A record of successful project completion • Proficiency with Microsoft Word, Excel, Project software and general MS Office file navigation as well as AutoCAD or SolidWorks • Proven ability to work with a variety of departments and personnel including the ability to work both in a team, and as an individual contributor • Knowledge of and experience implementing various manufacturing processes including: joining, machining, fabrication, finishing, and plating, etc. • Electrical and pneumatic experience, and PLC programming a plus • Good problem-solving abilities