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This role focuses on designing, building, and implementing intentionally right‑sized semi‑automated and automated manufacturing solutions for catheter processes. The Senior Staff Engineer owns automation concept development, fixture‑ and station‑level equipment design, prototyping, debug, validation, and deployment. Automation solutions in this role typically consist of semi‑automated fixtures and stations incorporating PLC control, pneumatics, servos, sensors, and machine vision, with capital investments generally ranging from thousands of dollars to low six‑figure projects. Designs emphasize poka‑yoke, error‑proofing, repeatability, and operator guidance, rather than fully automated, end‑to‑end production lines. Success is measured by reduction of operator dependence, reduced training, improved process consistency, and scalable transfer into high‑volume manufacturing in Costa Rica. The role partners closely with Manufacturing Systems Engineering, who own line architecture, line balancing, takt modeling, and staffing models, but is not the primary owner of those activities.

• Manual‑to‑Automation Conversion: Develop manufacturing processes with semi‑automation‑first thinking, converting manual catheter assembly steps into robust, repeatable, error‑proofed solutions while maintaining appropriate operator interaction.
• Automation & Equipment Development: Design or source cost‑effective, right‑sized custom equipment; define equipment and control architecture; integrate solenoids, pneumatics, servos, PLC control, and machine vision systems; develop URS/FAT/SAT documentation; lead equipment build, debug, and acceptance.
• Process Development: Automate catheter manufacturing processes including braiding, lamination, bonding, dispensing, tipping, soldering, and inspection with emphasis on risk reduction and process consistency.
• Validation & Documentation: Lead DOE, IQ/OQ/PQ execution, PFMEA contributions; generate engineering documentation—including work instructions, inspection procedures, protocols, and reports; design and execute process validation protocols.
• Cross‑Site Leadership: Support transfer of automated processes and fixtures to Costa Rica, mentor junior engineers, and support standardization of automation methods and reusable design patterns across sites; coordinate installation, debug, validation, and training.
• Cross‑Site Collaboration & Leadership: Provide technical leadership for automation initiatives supporting catheter manufacturing; partner with Manufacturing Systems Engineering to ensure clean integration of automated stations into scalable production lines.

• Bachelor’s degree in Mechanical, Manufacturing, Mechatronics, Electrical Engineering, or related field.
• 9–12 years of experience in manufacturing automation, ideally involving complex, small‑scale assemblies.
• Hands‑on experience designing, building, and debugging semi‑automated fixtures or stations using PLC‑based controls.
• Proficiency in SolidWorks (models, assemblies, drawings).
• Minitab experience a plus.
• Experience with robotics, motion systems, machine vision, sensors, and automated dispensing equipment.
• Familiarity with materials used in catheter assemblies.
• Experience in the medical device industry or other highly regulated manufacturing environments.
• 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, exercise sound technical judgment, and influence automation strategy and technical direction.

• 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).

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.