Process Development Engineer, Senior Staff

Job Description:

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.

We take pride in being a leader in the medical technology space and are driven by a passion to create products that enable next-generation minimally invasive procedures.

We are looking for a Process Development Engineer, Senior Staff to join our Austin, TX team! As a uniquely qualified candidate, you will: 

Position Summary

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, reduce 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.

Key Responsibilities:

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; and 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, and generation of technical documentation supporting automated processes.

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.

Validation & Documentation

• Lead process characterization, DOE studies, and statistical validation activity.
• Generate engineering documentation including work instructions, inspection procedures, protocols, and reports.
• Design and execute process validation protocols (IQ/OQ/PQ).
• Contribute to PFMEAs and risk analyses with emphasis on automation‑related failure modes and controls.

Cross‑Site Collaboration & Leadership

• Provide technical leadership for automation 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 semi‑automated fixtures, control philosophies, and equipment architectures across sites.
• Partner with Manufacturing Systems Engineering to ensure clean integration of automated stations into scalable production lines.

Education & Experience

• 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 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.