Research And Development Engineer

About the Role

Engineer the processes that give medical devices a second life. This role supports the design and development of processes behind restoring previously used healthcare products to like-new condition, relying heavily on reverse engineering, process validation, and equipment qualification. You'll define 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 and is not eligible for remote or hybrid work.

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

Requirements

• 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, gages, 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

Working Conditions

• Office environment with frequent sitting, walking, standing, kneeling, and occasional climbing
• Lab environment, including proper use of appropriate PPE for handling used medical devices (smocks, foot covers, safety goggles, face shield, hair net, and latex-free gloves for extended periods)
• Frequent use of hand-eye coordination while using equipment and tools
• Visual capacity including depth perception, color vision, and peripheral vision enabling operation of office machinery, laboratory equipment, and tools
• Light physical effort required by handling objects up to 30 pounds occasionally and up to 15 pounds frequently

Why Join Vein360

You'll gain broad, hands-on engineering experience across the full device reprocessing lifecycle, with real ownership over process design and validation work in a mission-driven, sustainability-focused industry.