R&D Engineer - Medical Device Reprocessing (On-Site)

Vein360; Blue Ash (OH); On-site; USD 85,000 - 105,000; Full time

Job summary

Vein360 is seeking an R&D Engineer to design and develop processes for restoring used healthcare devices to like-new condition. The role emphasizes reverse engineering, process validation, and equipment qualification, guiding requirements across medical technologies based on use and operation.

The position is full-time and on-site at the Cincinnati, OH facility, with reports to the R&D Manager or designee. You will contribute to documentation, test plans, and regulatory alignment.

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering field.
• 4+ years of medical device experience or closely related field.
• Working knowledge of CAD software such as SolidWorks or Creo preferred
• Ability to operate light machine tools, gauges, and laboratory instruments
• Proficient in MS Office; knowledge of Visio and Project preferred
• 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

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.

Skills

Reverse engineering

DOE / statistics

Documentation

Process validation

Record-keeping

CAD (SolidWorks/Creo)

MS Office / Visio / Project

Equipment operation

Education

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Biomedical Engineering

Tools

SolidWorks / Creo

Job description

Vein360 is seeking an R&D Engineer to design and develop processes for restoring used healthcare devices to like-new condition. The role emphasizes reverse engineering, process validation, and equipment qualification, guiding requirements across medical technologies based on use and operation.

The position is full-time and on-site at the Cincinnati, OH facility, with reports to the R&D Manager or designee. You will contribute to documentation, test plans, and regulatory alignment.