Immediate need for Sr. Manufacturing Engineer to design and develop manufacturing processes, tooling, and fixtures to meet production schedules for medical device manufacturing, while enhancing productivity and product quality. This position will manage projects for manufacturing engineering, and will be responsible for practicing Quality System procedures and complying with its requirements.
Primary responsibilities include:
§ Design and develop manufacturing processes and related tooling and fixtures which are consistent with a zero defect level as well as low product cost. Interface with manufacturing technicians and machine operators.
§ Project management for product improvement and manufacturing engineering projects, lead multi disciplinary project teams, create project schedules. Determine sterilization and process validation requirements, manufacturing plans, cost analysis. Procure and manage contract manufacturers and suppliers.
§ Create accurate and timely manufacturing documentation including manufacturing procedures, materials records, preventative maintenance, bioburden and process control reports, etc.
§ Identify areas for cost reduction and process improvement using Six Sigma and Lean manufacturing techniques.
§ Support facilities engineering and planning when appropriate.
§ Adhere to design control procedures, general safety rules, company policies and procedures, GMP and FDA regulations.
§ BS degree in Engineering/Technical area and minimum 5+ years experience designing and developing manufacturing processes and equipment, and minimum 3 years experience in project management for manufacturing system development.
§ Experience with the design and processing of plastics injection molding/assembly and experience with statistical analysis is required.
§ Requires experience in regulated / medical device industry, including process control, pFMEA, and ergonomics.
§ Prefer certification in Six Sigma and Lean Manufacturing.
The manufacturing engineer will be responsible for hands on design tasks, as well as managing ongoing projects. Must have strong computer skills in Microsoft Office (including Word, Excel, and Outlook (MS Project a plus), experience with SolidWorks, and strong organization, interpersonal, and communication skills. This Engineer must be self directed detail oriented, and able to manage multiple priorities, be able to objectively identify technical problems, and create solutions, and enjoy working in fast paced, results driven environment.
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