R&D Engineer

Vein360Blue Ash, OH
Onsite

About The Position

Vein360 is looking for an R&D Engineer to support the design and development of processes behind restoring previously used healthcare products to like-new condition. This role relies heavily on reverse engineering, process validation, and equipment qualification--defining requirements for a broad range of medical technologies based on their intended use and principle of operation. This position is based full-time at our Cincinnati, OH facility. It is not eligible for remote or hybrid work. You'll play a key hands-on role in building the processes, test methods, and documentation that support safe, compliant device reprocessing, while gaining broad exposure across engineering, quality, and regulatory functions.

Requirements

  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering field
  • 4+ years of medical device experience or closely related field
  • Ability to operate light machine tools, gages, and laboratory instruments
  • Proficient in MS Office
  • Highly organized with strong record-keeping skills
  • Understanding of Design of Experiments and statistical concepts
  • Capable of writing and following advanced technical procedures
  • Self-driven and ready to identify, analyze, and independently implement improvements to existing methods, procedures, processes, or products

Nice To Haves

  • Working knowledge of CAD software such as SolidWorks or Creo preferred
  • knowledge of Visio and Project preferred

Responsibilities

  • Design processes for the safe reprocessing of medical devices
  • Develop and implement standard test methods using core engineering skill sets
  • Generate test documentation that comprises the Design History File
  • Coordinate and execute test and validation trials
  • Comply with applicable regulations, including 21 CFR Part 820
  • Gather and maintain accurate, timely records associated with tests and validations
  • Work under a project plan, achieving milestones on schedule
  • Review, analyze, and document test data from both in-house and contract laboratories
  • Assist in the selection and qualification of new equipment
  • Stay current on relevant industry standards and regulations
  • Participate in team decision-making and routine meetings
  • Prepare documentation for design reviews and team meetings
  • Create and manage engineering change orders
  • Support a safe, healthy, and inclusive work environment

Benefits

  • mission-driven, sustainability-focused industry
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