Job Title: Senior Manufacturing Automation Engineer(Medical Devices)
Location: Scarborough, ME (Onsite)
Employment Type: Contract
Duration: 12-month contract (possible extension)
Salary: The hourly rate for this position is US$ 48 $52 per hour.
Benefits:
This is a contract position and does not include employer-provided benefits.
The Senior Manufacturing Automation Engineer is responsible for supporting and optimizing manufacturing equipment, automation systems, and process improvements in a regulated environment. This role focuses on troubleshooting, validation, and ensuring compliance with FDA and cGMP standards.
Responsibilities: Support and optimize manufacturing automation systems and equipment
Troubleshoot PLC-based systems, machine controls, and process issues
Lead root cause analysis and support CAPA investigations and resolution
Conduct FMEA and risk assessments for manufacturing processes
Support validation activities (IQ, OQ, PQ) and design of experiments (DOE)
Lead equipment upgrades and continuous improvement initiatives
Analyze equipment performance and implement process improvements
Develop and maintain SOPs, validation protocols, and technical documentation
Collaborate with cross-functional teams including Quality, Operations, and Engineering
Ensure compliance with FDA, cGMP, and ISO 13485 standards
Mentor junior engineers and support technical training initiatives
Bachelor's degree in Engineering (Mechanical, Electrical, or related field)
7+ years of experience in manufacturing or automation engineering
Strong experience with PLC systems and machine troubleshooting
Experience in regulated environments (FDA, cGMP, ISO)
Hands-on experience with CAPA, root cause analysis, and FMEA
Experience with validation activities (IQ, OQ, PQ)
Knowledge of Lean Six Sigma or DMAIC methodologies
Experience in medical device, pharma, or biotech industries
Knowledge of ISO 13485 and quality systems
Experience with statistical analysis tools
Familiarity with CAD and manufacturing documentation
Six Sigma certification is a plus
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Background Check:Background checks may be conducted in accordance with applicable laws.
Work Authorization:Applicants must be authorized to work in the United States.
If interested in this opportunity! Please send your updated resume at ahmed@intellectt.com or give me a call at +1-732-653-9472