Senior Manufacturing Systems Engineer – Process Design

Confluent Medical Technologies; Austin (TX); On-site; USD 120,000 - 180,000; Full time

Job summary

Confluent Medical Technologies in Austin, TX is seeking a Senior Staff Process Development Engineer – Manufacturing Systems to lead end-to-end line architecture and scalability across production lines, in collaboration with automation and operations teams.

You will own line design, capacity modeling, validation support (IQ/OQ/PQ), and cross-site deployments including Costa Rica transfers, mentoring engineers and guiding technicians while ensuring compliance in a regulated medical device

Qualifications

• 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

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.
• 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.
• 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.

Skills

Cross-functional leadership

SolidWorks

Six Sigma

Leadership

Process development

Education

Bachelor’s degree in Mechanical, Industrial, Manufacturing Engineering, or related field

Tools

SolidWorks

Minitab

Job description

Confluent Medical Technologies in Austin, TX is seeking a Senior Staff Process Development Engineer – Manufacturing Systems to lead end-to-end line architecture and scalability across production lines, in collaboration with automation and operations teams.

You will own line design, capacity modeling, validation support (IQ/OQ/PQ), and cross-site deployments including Costa Rica transfers, mentoring engineers and guiding technicians while ensuring compliance in a regulated medical device