This opportunity is a Manufacturing Engineering role supporting Medical Device Manufacturing. This Engineer will monitor the quality and performance for assigned manufacturing line(s) as well as drive continuous improvements through process development, root cause analysis and systematic problem solving. This Engineer will have the opportunity to participate on multidisciplinary teams, work with emerging technology and gain hands on Engineering experience.
- Process and Project Engineering support for Medical Device Manufacturing.
- Provides Process Engineering support for existing processes, including hands-on equipment troubleshooting and failure analysis for milling machines, lathes and other computer integrated electro-mechanical systems.
- Supports activities associated with scrap reduction, Non-Conformance investigations, Corrective and Preventative Actions.
- Participates in and leads continuous improvements to existing processes using Process Excellence tools and LEAN principles.
- Provides input on creative ways to reduce costs by streamlining processes and systems.
- Supports new equipment acquisition efforts including machine selection, installation, validation, employee training, and other related equipment responsibilities as required.
- Coordinates production line reconfiguration and machine move activities, including equipment arrival, positioning, and scheduling of support groups.
- Develops project schedules and assists in tracking costs, preparing status reports, conducting meetings, documenting, and communicating progress to management.
- Assists in writing and updating standard operating procedures and conducts training of Manufacturing Personnel.
- Encourage/Own open communication and exchange of information within the Manufacturing Engineering, Quality Engineering and various site support groups.
- Train to and comply with all internal procedures, applicable regulations and standards.
EDUCATION AND EXPERIENCE REQUIREMENTS
- Preferred: Bachelor's Degree in Mechanical Engineering, Manufacturing/Industrial Engineering, Biomedical Engineering or a related field.
- Accepted: Associates Degree in an Engineering related field plus 5 years of relevant experience in an Engineer or Technician role.
- Accepted: No Degree, with Ten years relevant experience in an Engineer or Technician role in an Engineering field.
ADDITIONAL EXPERIENCE AND SKILLS
- Experience with hands on failure analysis and equipment troubleshooting required.
- Project management and strong organizational skills required.
- Strong written, verbal communication, and computer skills required.
- Experience with FDA regulations or ISO standards preferred.
- Experience with SAP, AutoCAD, PTC Creo and MS Project desirable.
- Experience with automated systems, vision systems and material handling systems desirable.
- Experience with metal cutting equipment such as milling machines, lathes or grinding machines desirable.
- Must be willing to work in conditions that may be warm, cold, noisy and moderately oily.
- Must be willing to support global projects including up to 5% domestic travel.
- Must be willing to adjust schedule to support 2nd or 3rd shift and weekend operations as needed.
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