Process Development Engineer, Senior Staff

Senior Staff Process Development Engineer – Manufacturing Systems (Austin, TX) Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking their projects from rapid prototype through high-volume production. Our unparalleled technical expertise, proven experience, and deep partnership with our clients allow us to deliver world-class medical devices through innovative materials science, engineering, and manufacturing. Our primary capabilities include Nitinol components, balloon expandable stents and catheters, delivery systems, biomedical textiles, access kits, and guidewires. This role strengthens the manufacturing system architecture that enables predictable, scalable execution. Position Summary This role focuses on manufacturing line design, process flow, capacity modeling, and scalability. The Senior Process Development Engineer – Manufacturing Systems owns end-to-end manufacturing line architecture, performance, and scalability. This role defines how processes flow, scale, and validate across production lines while partnering with Automation Engineering, who own custom equipment design and detailed machine controls. Key Responsibilities Manufacturing Line Design & Flow: Design end-to-end process flows, line layouts, takt models, and WIP strategies. Industrial Engineering & Scaling: Perform capacity analysis, bottleneck identification, and staffing optimization. Systems Integration: Integrate manual and automated steps into cohesive lines; define high level equipment specifications, placement and line interfaces in partnership with automation partners. Risk, Data & Validation Support: Support PFMEA from a manufacturing system perspective; ensure line readiness for IQ/OQ/PQ. Cross-Site Deployment: Support Costa Rica transfers, ramp planning, and manufacturing readiness. Validation & Documentation Lead process characterization, DOE studies, and statistical validation activity. Generate line-level engineering documentation including work instructions, inspection procedures, protocols, and reports. Design and execute process validation protocols (IQ/OQ/PQ) from a line and system readiness perspective. Contribute to PFMEAs and risk analyses. Cross-Site Collaboration & Leadership: Provide technical leadership for line development initiatives supporting catheter manufacturing. Support transfers to Costa Rica by coordinating installation, debug, validation, and training. Mentor junior engineers and provide technical guidance to technicians (without direct managerial responsibility). Support standardization of production lines, equipment interfaces, and validation approaches across sites. Education & Experience Bachelor’s degree in Mechanical, Industrial, Manufacturing Engineering, or related field. 9–12 years of experience in manufacturing systems, industrial engineering, or process development within regulated environments. Demonstrated experience scaling complex, small-scale assembly processes into stable, high-volume production lines. Experience defining line architecture, equipment requirements, staffing models, and capacity plans in collaboration with automation and operations teams. Proficiency in SolidWorks (models, assemblies, drawings). Minitab experience a plus. Familiarity with materials used in catheter assemblies. Experience in Medical device industry or other highly regulated manufacturing environment. Demonstrated experience in process characterization, validation, and control (DOE, IQ/OQ/PQ, SPC). Green or Black Belt certification a plus. Demonstrated ability to lead cross-functional engineering efforts and influence technical direction. Work Environment & Physical Requirements Work performed in office, engineering lab, and Class 8 cleanroom environments. Ability to lift up to 50 lbs. Ability to stand at development benches or workstations for extended periods. Occasional cleanroom gowning required. Travel up to 50%, primarily to Costa Rica, condensed around critical project phases (not continuous). Additional Information We regret that we are unable to sponsor employment visas or consider individuals on time‑limited visa status for this position. Confluent Medical Technologies is an Equal Opportunity Employer. Only qualified candidates will be contacted. #J-18808-Ljbffr CONFLUENT MEDICAL TECHNOLOGIES INC.