R&D Engineer

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

R&D Engineer

Location: Cincinnati, OH (100% On-Site)

Engineer the processes that give medical devices a second life.

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.

Reports to: R&D Manager or designee

Why This Role Matters

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.

What You'll Do

• 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

What You Bring

• 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

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.

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. Includes donning of smocks, foot covers, safety goggles, face shield, hair net, and latex free gloves for extended periods of time. 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.

Equal Employment Opportunity Statement

Vein360 is an Equal Opportunity Employer. Employment decisions are based on business needs, job requirements, and individual qualifications. Vein360 does not discriminate on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other status protected by applicable federal, state, or local law.

Vein360 is committed to providing reasonable accommodations to qualified individuals with disabilities in the application process and throughout employment, as required by applicable law.

Disclaimer

This job description and above statements are intended to describe the general nature and level of work performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, qualifications, or working conditions. Duties, responsibilities, and activities may change at any time, with or without notice, based on business needs.