Machine/Automation Engineer

Description POSITION SUMMARY: The Machine/Automation Engineer will serve as a key contributor within the engineering team, responsible for leading the design, implementation, and improvement of automated systems and production machinery. This is a hands-on role ideal for a highly skilled engineer with a minimum of 5 years of direct experience in automation, machine design, and manufacturing support within a regulated environment. ESSENTIAL FUNCTIONS: Independently lead the design and deployment of custom automation systems and specialized production equipment. Develop mechanical designs and detailed drawings using SolidWorks; oversee fabrication and assembly. Program and debug PLCs, HMIs, and control systems (preferably Omron and/or Allen-Bradley). Robotic programming and debug (Epson) prefered Perform root cause analysis and implement corrective actions for complex equipment and process issues. Support validation efforts including IQ/OQ/PQ for new and modified equipment in compliance with FDA and ISO 13485. Collaborate with cross-functional teams to evaluate, improve, and scale manufacturing processes. Identify opportunities for cost savings, cycle time reductions, and quality improvements through automation. Author and maintain technical documentation including specifications, change orders, work instructions, and validation reports. Provide technical guidance and mentorship to junior engineers and technicians. Manage external vendors, suppliers, and contractors as needed for machine builds and component sourcing. QUALIFICATIONS, SKILLS, ABILITIES REQUIRED: Strong mechanical aptitude and hands-on approach to engineering challenges. Expertise in SolidWorks and engineering documentation practices. Proven experience with PLC and HMI programming, sensors, pneumatics, and motion control systems. Demonstrated ability to take projects from concept through production deployment independently. Familiarity with cGMP, FDA regulations, and ISO 13485 standards. Excellent troubleshooting, problem-solving, and communication skills. Strong organizational skills and ability to manage multiple concurrent projects. Knowledge of plastics and plastics processing preferred. MS Project, MS Access, and experience working in a document-controlled environment are a plus. Requirements EDUCATION, EXPERIENCE REQUIRED: Bachelors degree in Mechanical, Electrical, Automation, or Industrial Engineering required. Minimum of 5 years of hands-on automation/machine engineering experience in a manufacturing environment. Demonstrated success managing automation or machine development projects. PLC programming experience (Omron, Allen-Bradley, or similar) required. Experience in medical device or highly regulated industries preferred. TRAINING REQUIRED: Centrix Orientation cGMP Training FDA & ISO 13485 Product Training Quality Manual Engineering SOPs (SOP-024, SOP-025, SOP-026, etc.) Lockout-Tagout (SOP-007) Emergency Action Plan (SOP-010) Hazcom (SOP-011)

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