Manufacturing Test Engineer
Katalyst HealthCares & Life Sciences
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 setting up, executing, and documenting test configurations for components, assemblies, and manufacturing equipment. Developing, refining, and optimizing test procedures, protocols, and validation methods to improve testing efficiency and product quality. Building, maintaining, troubleshooting, and operating prototype and production equipment. Supporting installation, startup, debugging, qualification, and validation activities for new products and manufacturing equipment. Collaborating with suppliers, engineering, quality, and operations teams to ensure equipment and components meet design and production specifications. Supporting smooth transition of new products and processes into manufacturing environments. Maintaining detailed technical documentation including SOPs, validation records, test reports, component specifications, and process documentation. Providing onboarding, training, and technical guidance to testing and process personnel. Managing equipment, components, inventory, and procurement activities to support project timelines and production schedules. Supporting process development, equipment qualification, assembly process validation, and software-driven manufacturing systems. Ensuring compliance with manufacturing quality standards, regulatory requirements, and internal procedures.
Education and experience preferred include a Bachelor's degree in engineering, Manufacturing, Biomedical Engineering, Mechanical Engineering, or related technical field. Three or more 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.
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