Senior Staff Process Development Engineer-Automation

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.

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.