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.

EDUCATION, EXPERIENCE REQUIRED:

• Bachelor’s 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)