Automation Engineer - Medical Device
Role summary
Seeking a skilled Automation Engineer with 4-5 years of experience in the medical device industry to support automation, control systems, and manufacturing processes in a regulated environment. The role requires hands-on experience with PLCs (Allen-Bradley, Siemens), SCADA systems, and a strong understanding of GMP and validation requirements (IQ/OQ/PQ). Responsibilities include designing, developing, and maintaining automation systems, troubleshooting issues, ensuring compliance with FDA, GMP, and ISO 13485 standards, and developing technical documentation. Collaboration with cross-functional teams is essential.
Job Title: Automation Engineer – Medical Device
Location: United States
Duration: 12 Months
Overview
We are seeking a skilled Automation Engineer with 4–5 years of experience in the medical device industry to support automation, control systems, and manufacturing processes in a regulated environment. The ideal candidate will have hands-on experience with PLCs, SCADA systems, and a strong understanding of GMP and validation requirements.
Key Responsibilities
- Design, develop, and maintain automation and control systems for medical device manufacturing
- Program and troubleshoot PLCs (Allen-Bradley, Siemens, etc.) and HMI/SCADA systems
- Support equipment integration, commissioning, and qualification (IQ/OQ/PQ)
- Work closely with cross-functional teams including Manufacturing, Quality, and Validation
- Troubleshoot automation issues related to equipment, controls, and production systems
- Ensure compliance with FDA, GMP, and ISO 13485 standards
- Develop and maintain technical documentation, SOPs, and validation protocols
- Support continuous improvement initiatives to optimize manufacturing processes
- Assist in change control, deviations, and CAPA activities
Required Qualifications
- Bachelor’s degree in Engineering (Electrical, Automation, Mechatronics, or related field)
- 4–5 years of experience in automation engineering within the medical device industry
- Hands-on experience with:
- PLC programming (Allen-Bradley / Siemens)
- HMI / SCADA systems
- Strong understanding of GMP, FDA regulations, and ISO 13485
- Experience with equipment validation (IQ/OQ/PQ)
- Strong troubleshooting skills across electrical, controls, and automation systems
Preferred Qualifications
- Experience with robotics or vision systems
- Knowledge of MES systems
- Familiarity with data integrity and 21 CFR Part 11
- Experience in high-volume manufacturing environments
