Manufacturing Engineer/Production Supervisor
Director, Manufacturing Operations/ or President
Regular, Full-time, Exempt
Manufacturing Engineer will develop and improve processes and equipment to facilitate the manufacture of new, redesigned, and current products to meet established specifications and cost limits. Responsible for supervising and scheduling the activities of production employees, materials and equipment to attain production goals while ensuring the quality of the products as a top priority. Assists with all personnel related functions related to production assembly staff including hiring, training and performance evaluations. Support new product/process development.
- Evaluates and develops innovative solutions to complex product and production problems through identification and implementation of advanced manufacturing processes including conducting process analysis, applying knowledge of product design, fabrication, assembly, tooling, automation and materials.
- Supports continuous improvement and design enhancement of current products to improve quality and cost.
- Continuously track, monitor, and report production performance. Maintains day-to-day records and reports of progress.
- Attains goals for production output, yield, efficiency, cycle time and space utilization.
- Analyzes and plans work force utilization, space requirements, workflow, and designs layout of equipment and workspace for maximum efficiency. Evaluates line efficiency, cycle time, and TAKT time.
- Provides feedback to Quality and R&D Teams.
- Specifies production equipment and provides appropriate cost justification for investment.
- Defines execution of Equipment Qualification and Process Validation Protocols (IQ, OQ, PQ) and provides training for Production Team Members on Standard Operation Procedures and Work Instructions for new processes and equipment.
- Executes engineering and quality methods analysis including FEA, Tolerance Analysis, DOE, SPC, FMEA, Pareto Charts, Process Capability, Root-Cause Analysis, etc.
- Provides Design for Manufacturability (DFM) input.
- Ensures proper documentation is completed to meet quality systems requirements.
- Ensures employee safety and compliance to applicable Federal, State and Company safety regulations.
- Works under very general direction. Independently plans work and determines and develops approach to solution.
- Bachelor’s Degree in Engineering: Mechanical, Industrial, Manufacturing or Process disciplines.
- Requires two or more years of Manufacturing Engineering experience with process design, development and deployment.
- Extensive knowledge of fundamental process development practices including problem definition, specification and requirements development, concept selection, proof of concept, process development, testing, implementation and industrialization.
- Experience with tooling design and equipment integration.
- Knowledge of plastic assembly and joining methods. Experience with injection molded and extruded plastic parts, assembly process and methods.
- Knowledge and application of Medical Device Manufacturing requirements for compliance with applicable regulating bodies: FDA, ISO, OSHA, EEC MDD, ASTM, ANSI, et al.
- Fluency with Microsoft Office software (Word, Excel, PowerPoint)
- Experience with Solidworks or similar design tools.
- Experience with statistical analysis software (i.e. JMP, Minitab) desired
Equipment to be used in Performance of Job:
- Basic machine tools, shop tools, instrumentation, and test equipment.
- Copy/Scan/Fax Machine