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Process Engineer

Fusion Life Sciences Technologies LLC, Houston, Texas, United States

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Title: Contract Process Engineer Location: Cincinnati, Ohio Visa Type: USC and GC Overview Seeking a Contract Process Engineer to support the design, development, optimization, and scale-up of manufacturing processes for medical device and drug-delivery components. The contractor will work with cross-functional teams and suppliers to deliver robust, manufacturable solutions. Key Responsibilities Develop, optimize, and validate component and assembly manufacturing processes. Support DFM/A activities and translate product requirements into process outputs. Conduct process characterization, capability studies, and statistical analyses. Partner with R&D, Quality, Regulatory, Supplier Engineering, and Operations throughout development. Support equipment debug, characterization, FAT, and qualification activities. Troubleshoot manufacturing and compliance issues and support process transfer to production sites. Preferred Background 6+ years in process development within a regulated industry. Strong understanding of component fabrication and assembly processes. Experience with DFMA, FMEA, and applied statistics (MSA, process capability). Experience with equipment commissioning (debug, characterization, FAT, validation). Familiarity with Lean, Six Sigma, or similar methodologies. Experience supporting commercialization or working with global teams/suppliers. Prior J&J or MedTech experience is strongly preferred.