Irvine, California, United States
Mechanical Engineer with practice in the medical devices regulated industry. Ensure compliance of manufacturing and production processes with an internal and external safety, quality, and regulatory standards requirements. Able to develop components and products from concept to finished product. Strong planning skills with the ability to conceptualize and analyze complex designs. Ability to elaborate designs in Spanish/English language and excellent organization skills. Able to apply knowledge of machinery operations and the working properties of the material to design products and prototype tooling. Skills machine operation, Solid Works, Pro-E, AutoCAD, MS Office, and Minitab. Consistently demonstrate leadership skills, decision-making capability, initiative, and resourceful in responding to job challenges.
• Analyze and review existing conditions of production line to design fixture to perform the operation according with COS transformation and operators request. • Collaborate with the DMAIC analysis, design and decision of the COS transformation. • Keep update training and certification also knowledge to buy and order tooling through Medtronic SAP AND ERP system. • Create and review tooling concept with the manufacturing engineering team and execute using ProE and Solid Works for 3D modeling and Auto Cad for 2D drawing and bring the design to the reality by manufacturing it using metal working and material for clean room working. • Rebuilt, adjust and assembling new COS working station and fixtures also planning and implementation of 5S method in machine shop.
• Direct and coordinate production, operations, quality assurance, testing and maintenance of the plants. • Supervise and lead planning, develop projects and oversee production and quality control to Cardinal Health, Haraeus, Arthrocare, Abott, Medisearch and Iradimed. • Analyze and review new products, designs and specifications for potential quality issues; provides tangible feedback and proposes changes to improve products quality and minimize risk of failures for Heraeus protocol. • Consolidates and analyze reports, test data, and process results for assigned components to identify trends and issues, perform root-cause analysis and propose resolutions to tiromat machine. • Revise methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products Abott. • Prepare the budgets and bids for the Engineer Department, in charge of the Manufacturing Plant facilities. • Hire, train, and motivate team members on a proactive basis. • Responsible of OSHA assessments, full report and implement corrective actions.