Manager Fmea Jobs Near Me

The Engineer II, Molding is responsible for supporting injection molding improvements through adherence to established product design, scientific injection molding process, tooling, resin, and equipment. The key responsibility of this position is to exercise judgement with injection molding resources, support projects within a product family and take action while adhering to defined procedures. The incumbent will also liaise with the Tooling, Molding, Engineering, Production, Quality, and Maintenance departments. The Engineer II completes intermediate projects with guidance from more experienced engineers and managers. They gain exposure to some of the complex tasks within the job function and are occasionally directed in several aspects of the work.

This position is 100% onsite at our Dublin, OH manufacturing facility.

• Immediate expectations
  • Support Molding Engineering for continuous process and product improvements
  • Implement Molding Engineering injection molding process development, process monitoring, and tool qualifications
  • Lead project and timelines for Validation (IQ/OQ/PQ) activities
  • Analyze and specify equipment performance and identify system improvements
  • Implement Cost Savings - Scrap, DPM, OEE Improvement, Scrap reduction, Setup Improvements
  • Close coordination with the resources assigned to the product family (tool room, Process Engr, Quality Engr)
  • Assist in completion of CAPA tasks and deliverables (Corrective and Preventive)
  • Conducts independent analysis and develops solutions to problems
  • Develops approaches and designs where precedent usually exists
  • Performs developmental and/or test work that relies heavily on a comprehensive knowledge of theory and design
  • Writes detailed design specifications
  • Receives general project direction. Solicits input from more experienced engineers.
  • Work on special projects as they arise
• Long term expectations
  • Initiate and manage projects with adherence to program management guidelines as they relate to new/existing molding equipment, tooling, and materials
  • Coordinate efforts with the Materials Group to assess vendors and provide materials technical information
  • Build productive relationships internally and externally
• Assists in training new/current employees with respect to documentation, use of equipment, laboratory techniques and department procedures.
• Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration.

• Competent in your domain. Familiar with other areas of domain expertise within the team.
• Scientific Injection Molding training/certification or proof of understanding of the model; process, tooling, part design, materials, and equipment
• Understanding of strength of materials, automation, thermoplastic and LSR injection molding, part assembly, fixturing, testing, and process control techniques
• Risk Management-> FMEA generation
• Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.) - use of Minitab Software for analysis
• Knowledge of the Medical Device Industry and familiarity with FDA QSR regulations
• Has a basic understanding of best practices. Has a basic to intermediate understanding of engineering discipline
• Have awareness of the broader product strategy and contribute to it
• Ability to receive general project direction and solicit input from more experienced engineers
• Requires the ability to independently make decisions that impact the attainment of project objectives

• Must be at least 18 years of age
• Bachelor’s degree from an accredited college or university
• 3-5 years’ experience in Injection Molding Industry

• This job operates in a professional office environment and routinely uses standard office equipment
• Perform work in a clean room environment
• While performing the duties of this job, the employee may be required to sit or stand for long periods of time; depending on the machine they are operating
• Must be able to occasionally move and lift objects of up to 25 lbs
• Typically requires travel less than 5% of the time