Job Description
An employer is seeking a NPD Equipment Process Engineer for a long term opportunity in the Cincinnati/Dayton, OH area. The responsibilities will be located at the supplier site in Dayton while reporting to the Blue Ash site as the home office to deliver reports to the NPD team. The Equipment Process Engineer will conduct structured equipment design reviews with equipment integrators to assess alignment to manufacturing requirements, defined user needs, and engineering standards, develop and execute process characterization activities for new production equipment, author and execute test method validation (TMV) protocols, including Gauge R&R and machine capability studies as needed and equipment documentation, including:
Process characterization plans, FMEAs, Test protocols and reports, software and equipment validation documentation
A background in process characterization and on-site support during equipment power-on, debug, and initial characterization at integrator and manufacturing locations is required. They will document results, observations, deviations, and recommendations to support equipment stabilization and readiness. Supporting downstream IQ, OQ, and PQ execution as equipment progresses toward production will be further along in this project in order to get the new product line up and running.
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Required Skills & Experience
5+ years of experience in Equipment Development Engineering and/or Process Engineering in a medical device or regulated industry
Hands-on experience supporting new product development (NPD) equipment builds
5+ years of experience with process characterization, equipment testing, and machine capability studies
Proven experience writing and executing Test Method Validation (TMV) protocols, IQ, OQ, and PQ documentation and Gauge R&R studies
Experience working directly with manufacturing or production equipment (debug, testing, characterization)
Solid understanding of GMP-regulated environments
Experience developing and maintaining technical documentation within a formal document control system (Windchill preferred)
Ability to work on-site during critical build, debug, and validation activities
Nice to Have Skills & Experience
Bachelor’s degree in Mechanical, Industrial, Electrical Engineering, or related discipline
Prior experience working with equipment integrators during equipment build and commissioning
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.