Advanced Manufacturing Engineer; AME
Listed on 2026-07-01
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Manufacturing / Production
Manufacturing Engineer, Quality Engineering, Validation Engineer -
Engineering
Manufacturing Engineer, Quality Engineering, Process Engineer, Validation Engineer
Job Title
Coordinates and supports suppliers for manufacturing of custom equipment/tooling. Coordinates purchase and delivery of equipment/tooling. Coordinates installation of equipment/tooling. Develops and executes IQ and OQ protocols and reports. Develops and executes test method validations/gage R&R. Generates and issues for approval SOPs and manufacturing procedures. Develops and executes component qualifications. Develops and executes PQ and PPQ protocols and reports. Develops manufacturing capacity analysis.
Develops and executes process characterizations/design of experiments (DOE). Develops documentation/justification for assigned capital projects. Complies with cGMP's, quality standards, and established policies and procedures. Executes other duties assigned by his supervisor.
Education and/or experience:
Bachelor's degree in engineering. Experience in the medical device/pharmaceutical industries: yes. 5+ years of experience in the following fields: manufacturing, new product transfers, product/process development.
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