Manufacturing Test Engineer

Katalyst Healthcares & Life Sciences

Cincinnati, OH

JOB DETAILS
SKILLS
Assembly Equipment, Biomedical Engineering, Debugging Skills, Documentation, Equipment Validation, Identify Issues, Maintain Compliance, Manufacturing, Manufacturing Assembly, Manufacturing Engineering, Manufacturing Equipment, Manufacturing Operations, Manufacturing Systems, Manufacturing/Production Testing, Mechanical Engineering, Medical Equipment, Onboarding, Procedure Development, Process Development, Process Engineering, Process Manufacturing, Process Validation, Product Testing, Production Schedule, Production Specifications, Production Support, Prototyping, Purchasing/Procurement, Quality Assurance Methodology, Quality Metrics, Regulatory Requirements, Standard Operating Procedures (SOP), Startup, Technical Leadership, Technical Writing, Testing, Training/Teaching, Validation Plan, Validation Testing
LOCATION
Cincinnati, OH
POSTED
Today
Manufacturing Test Engineer

We are seeking a skilled Manufacturing Test Engineer to support testing, validation, equipment setup, and process development activities within a regulated manufacturing environment. The ideal candidate will have experience supporting prototype and production equipment, developing test procedures, troubleshooting systems, and ensuring smooth transition of products into manufacturing operations.

The candidate should possess strong knowledge of manufacturing engineering support, equipment validation, process qualification, documentation practices, and medical device regulatory requirements.

Roles and responsibilities include:

  • Set up, execute, and document test configurations for components, assemblies, and manufacturing equipment.
  • Develop, refine, and optimize test procedures, protocols, and validation methods to improve testing efficiency and product quality.
  • Build, maintain, troubleshoot, and operate prototype and production equipment.
  • Support installation, startup, debugging, qualification, and validation activities for new products and manufacturing equipment.
  • Collaborate with suppliers, engineering, quality, and operations teams to ensure equipment and components meet design and production specifications.
  • Support smooth transition of new products and processes into manufacturing environments.
  • Maintain detailed technical documentation including SOPs, validation records, test reports, component specifications, and process documentation.
  • Provide onboarding, training, and technical guidance to testing and process personnel.
  • Manage equipment, components, inventory, and procurement activities to support project timelines and production schedules.
  • Support process development, equipment qualification, assembly process validation, and software-driven manufacturing systems.
  • Ensure compliance with manufacturing quality standards, regulatory requirements, and internal procedures.

Education and experience required:

  • Bachelor's degree in engineering, Manufacturing, Biomedical Engineering, Mechanical Engineering, or related technical field preferred.
  • 3+ years of experience in manufacturing test engineering, process engineering, or equipment validation environments.
  • Experience in regulated manufacturing or medical device industries preferred.
  • Equivalent combination of education and relevant work experience will also be considered.

About the Company

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Katalyst Healthcares & Life Sciences