Equipment Validation Engineer

An employer in the Cincinnati, OH area is seeking a Equipment Validation Engineer for a long-term opportunity. This Validation Development engineer will support a project focused on a handheld commercial product launch. This Engineer will need to have experience overseeing a manufacturing cell and will be required to validate all phases of the manufacturing process (vision systems, component qualification, cell automation and documentation). This will be a mostly high-volume manual production assembly process with 500k units produced per year. The equipment development engineer will be validating equipment while working cross functionally with the lifecycle team to drive line movement and oversee the ongoing project schedule. Prior experience within the medical device industry will be a plus to help adhere to GMP standards. Minimal local travel will be required and the on-site responsibilities will be 3 days a week in Blue Ash. Comfortable with some international travel, paced to increase in 2027. Both front end development and then back-end process after validation experience, so full Lifecyle.

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5+ years experience in Equipment Development & Process Engineering (IQ, OQ, PQ)
Experience in New Product Development or R&D
5+ years of equipment characterization and validation experience (software, test methods, ect.)
Experience conducting Gage R&R studies. capability studies, FMEA
5 -10 years of experience working on manufacturing/production equipment (testing, machine test method development)
Understanding of GMP

Bachelor's Degree in Mechanical, Industrial or Electrical Engineering Strongly Preferred
Med Device Background
Windchill

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.