Manufacturing Engineer

2 days ago

Cincinnati, United States Redbock - an NES Fircroft company Full time

A fast-growing Medical Device company in Cincinnati is looking for a Manufacturing Engineer to join them for a 12-month contract, the project will kick off in January 2025. This project needs to be completed while working fully onsite.

This is a great opportunity for a junior-level or mid-level engineer to get hands-on experience supporting commercial manufacturing for critical medical devices. The engineer is needed because manufacturing volume is increasing along with the number of products that they make, the commercial manufacturing lines need support from both Operators and Manufacturing Engineers to support development, maintenance, and troubleshooting activities. Day to day responsibilities will involve investigating NCRs and process issues for troubleshooting among other areas detailed below. The engineer will join a team of 6 people, he or she will contribute to the organization through development, implementation, and maintenance of manufacturing processes with compliance to regulatory requirements. Equipment complexity ranges from manual fixtures and jigs to fully automated assembly and test machines.

Responsibilities:

  • Support process design and optimization through design of experiments and engineering studies
  • Support Manufacturing equipment specification, design, development, construction, or modification
  • Troubleshoot and implement solutions to aid in the manufacture of the product. Typical solutions require changes to assembly equipment and/or the modification of part/mold design and inspection criteria to improve the quality, reproducibility, efficiency or safety of the manufacturing processes
  • Some support of Equipment Qualification (FAT, SAT, IOQ) to meet regulatory requirements, and test protocols to challenge equipment performance against intended specifications
  • Standard Operating Procedures and Router creation, revision, and implementation including necessary change order, training and verification activities
  • Some support to develop test methods and fixtures to prove functionality of sub-assemblies and final product
  • Maintain and repair equipment
  • Author Quality System documentation to support all of the responsibilities above, including but not limited to change control, non-conformance reports, engineering protocols and reports, build protocols and reports, equipment forms, calibration forms, and preventive maintenance form
  • Provide project status updates to management


Requirements:

  • BS degree in Engineering
  • 1-4 years of Medical Device or Pharmaceutical industry experience as an engineer
  • Experience with medical device manufacturing and inspection technologies (heat staking, ultrasonic welding, press assembly, adhesives, leak testing, vision systems, manual assembly, discrete manufacturing, and robotics, preferred)
  • Experience in a high-volume manufacturing environment preferred, i.e., production 1M+ annual, cycle time < 3 second.
  • Understanding in Mechanical design fundamentals
  • Proficiency utilizing the MS Office Suite (Project, Word, Excel, PowerPoint, Visio, Outlook, Teams)
  • Familiar with Solid Modeling for part and assembly creation (SolidWorks strongly preferred)
  • Experience with spreadsheet and statistical analysis software packages (Excel and Minitab preferred)
  • Strong analytical and creative problem-solving skills
  • Strong verbal communication and technical writing skills
  • Ability to manage time effectively, prioritize tasks, set goals, and lead a varied workload to meet team objectives

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