Job Title: Controls Engineer
Location: North Haven, CT
Duration: 12 Months (Onsite)
About the Role: We are hiring a Controls Engineer for our client in the medical device industry. This role supports high-precision automated manufacturing lines for Class II/III medical devices. The ideal candidate will bring strong expertise in controls engineering, Rockwell automation platforms, and validation within regulated environments.
Key Responsibilities
- Design, develop, and optimize Rockwell Automation (Allen-Bradley) PLC and motion control programs for automated manufacturing equipment.
- Configure and troubleshoot vision inspection systems (Cognex/Keyence) to ensure reliable defect detection and in-line quality verification.
- Lead controls architecture reviews, safety assessments, and equipment readiness evaluations for new and existing production lines.
- Execute and document IQ/OQ/PQ validation protocols in compliance with FDA, ISO 13485, and internal quality standards.
- Collaborate with manufacturing, quality, and validation teams to troubleshoot automation issues and improve equipment uptime, yield, and cycle time.
- Support root cause analysis, CAPA activities, and continuous improvement initiatives using data-driven approaches.
- Work cross-functionally with process, mechanical, and software engineering teams to implement system upgrades and new technology.
Required Qualifications
- Bachelor’s degree in Electrical, Mechanical, Controls, Automation Engineering, or related field.
- 5+ years of experience in controls engineering, preferably in medical device or pharmaceutical manufacturing.
- Strong hands-on experience with Rockwell/Allen-Bradley PLCs, motion control systems, and HMI development.
- Experience with Cognex or Keyence vision systems.
- Proven experience executing IQ/OQ/PQ validations in regulated environments (FDA, ISO 13485).
Preferred Skills
- Experience supporting Class II/III medical device manufacturing.
- Knowledge of GMP, QMS, and regulatory compliance standards.
- Strong problem-solving skills with a focus on automation reliability and process optimization.
