What are the responsibilities and job description for the Manufacturing Automation Engineer - Medical Device position at Intellectt Inc?
Manufacturing Automation Engineer
Location: Westbrook, Maine (Onsite)
We are looking for a Sr. Manufacturing Automation Engineer to support manufacturing automation, process improvements, and compliance initiatives in a regulated environment.
Key Responsibilities:
• Support and improve manufacturing automation systems and processes
• Lead equipment upgrades, validation, and new implementations
• Troubleshoot automation systems, machine logic, and controls
• Perform root cause analysis and drive CAPA activities
• Develop and maintain SOPs, validation protocols, and technical documentation
• Ensure compliance with FDA, cGMP, and ISO standards
• Lead cross-functional teams and continuous improvement initiatives
Requirements:
• 3 years of experience in manufacturing automation/engineering
• Strong troubleshooting and root cause analysis skills (Lean Six Sigma preferred)
• Experience with validation (IQ/OQ/PQ) and DOE
• Knowledge of FDA, cGMP, and ISO regulations
• Bachelor’s degree in Engineering or related field