Automation Specialist

Job Title: Senior Automation Engineer Medical Device Manufacturing

Experience: 10+ years

Industry: Medical Devices / Life Sciences / Manufacturing

Location: Remote

Summary:

Senior Automation Engineer responsible for developing, implementing, and sustaining automation systems that support manufacturing, assembly, and testing of medical devices in compliance with ISO 13485 and FDA 21 CFR Part 820. The role involves managing PLC, SCADA, and robotic systems, ensuring process reliability, data integrity, and regulatory compliance across production operations.

Responsibilities:

• Designed and implemented automation solutions for medical device manufacturing and test systems to improve reliability and throughput.
• Programmed and configured PLCs, HMIs, and motion control systems (Allen-Bradley, Siemens, Beckhoff, Omron).
• Developed and optimized automated assembly and inspection equipment, integrating sensors, vision systems, and robotics.
• Supported validation of automation systems (URS, FDS, FAT, SAT, IQ/OQ/PQ) in line with ISO 13485 and FDA 21 CFR Part 11/820 requirements.
• Performed troubleshooting, preventive maintenance, and root cause analysis on automated equipment and control systems.
• Managed system integration between PLCs, MES, and data acquisition systems to ensure traceability and data integrity.
• Ensured all automation activities adhere to QMS, CAPA, and change control procedures.
• Collaborated with R&D, Manufacturing Engineering, and Quality teams for process scale-up and equipment qualification.
• Prepared technical documentation, operating procedures, and training materials for maintenance and production teams.
• Supported continuous improvement projects and provided technical mentorship to junior engineers.