Manufacturing Engineer

Requirements

• Lead continuous improvement programs to improve, manufacturing processes, equipment performance and reliability. Maximize Mean Time Between Failure (MTBF), Operational Uptime and minimize Mean Time To Repair (MTTR)
• Support Subject Matter Experts (SMEs) during the design and development ofnew equipment. analyze equipment malfunctions and failures and accordingly develop corrective actions
• Develop improvements to enhance equipment reliability and scalability
• Develop preventive maintenance procedures to reduce equipment and tooling failures
• Maintain documentations for equipment installation, maintenance and troubleshooting procedures for reference purposes
• Responsible for manufacturing methods and their transfer into production
• Follow SOP on re-validation of existing equipment, tooling and processes
• Provide technical assistance and engineering support to the manufacturing floor in ensuring production of quality products. Work with other support departments to maintain on-time delivery of goals
• Work with Quality Control team to generate, update and implement all manufacturing engineering related requests, vendor contact and auditing specification
• Perform Root Cause Analysis and Address CAPA on Manufacturing Non-Conformances
• Create comprehensive Manufacturing Documentation (MPI’s, LHR’s, WI’s)
• Complete projects, report status, and document lessons learned in an efficient manner

Education and/or Job Experience

• BS in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or similar related field
• 5+ years of engineering experience in manufacturing, design, and assembly
• 2+ years of experience in Design for Excellence (DFX), Electromechanical equipment, Electrothermal equipment, and various testing equipment
• SolidWorks or CAD modeling software
• Experience in new product development, introduction processes and procurement protocols
• Must be detail oriented, focused and able to produce accurate and professional documents
• Must have excellent interpersonal skills and ability to communicate needs and demands in an effective manner.
• Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
• Prior experience with FDA regulations and ISO, cGMP, QMS standards, etc.

Preferred Qualifications

• Master’s degree in engineering
• Knowledge/experience with plastic injection molding
• Knowledge/experience with DOE, SPC, JMP /Minitab
• Experience with metal stamping, laser cutting and chemical etching
• Familiarity with and sterilization process and aseptic environment
• PLC programming