Senior Controls Engineer Medical Devices

Role Summary

This position supports high-precision automated manufacturing lines for Class II/III medical devices. The role requires deep expertise in controls engineering, Rockwell automation platforms, and validation of regulated systems. The engineer will design, program, troubleshoot, and optimize controls architectures that drive equipment reliability, throughput, and compliance.

• Develop, modify, and optimize Rockwell Automation (Allen‑Bradley) PLC and Motion Control programs for automated equipment.
• Design, integrate, and troubleshoot vision inspection systems (Cognex/Keyence) to ensure robust defect detection and in‑line quality verification.
• Lead controls architecture reviews, safety evaluations, and equipment readiness assessments for new and existing lines.
• Execute IQ/OQ/PQ protocols, ensuring alignment with FDA, ISO 13485, and internal QMS requirements.
• Partner with manufacturing, quality, and validation to resolve automation issues and drive equipment uptime, scrap reduction, and cycle‑time improvements.
• Support root cause investigations, CAPA activities, and continuous improvement initiatives using data‑driven methods.
• Collaborate with process, mechanical, and software engineering teams to implement changes, upgrades, and new technology introductions.

• Bachelor’s degree in Electrical, Controls, Automation, or related engineering field.
• 5+ years of controls engineering experience (medical device or pharmaceutical manufacturing will be preferred).
• Strong hands‑on experience with Rockwell PLCs, Motion Control, and HMI development.
• Proficiency with Cognex/Keyence vision systems.
• Demonstrated experience executing IQ/OQ/PQ validation in regulated environments.