Automated Assembly Equipment, Change Control, Change Management, Code of Federal Regulations, Computer Systems, Control Engineering, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Electrical Engineering, Electromechanics, Engineering, Engineering Management, Equipment Validation, FDA (Food and Drug Administration), ISO (International Organization for Standardization), Identify Issues, International Electro-Technical Commission (IEC), Manufacturing, Manufacturing Engineering, Manufacturing Equipment, Medical Equipment, Minitab, Process Improvement, Process Validation, Root Cause Analysis, Standard Operating Procedures (SOP), Statistics, System Validation, United States Department of Energy (DOE), Validation Plan
Hello,
I hope you're doing well.
My name is Purna, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for aSenior Manufacturing Engineer based in North Haven, CT (Onsite)with one of our prestigious clients. I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at
purnasree.u@intellectt.com
.Role: Senior Manufacturing Engineer.
Location: North Haven, CT (Onsite)
Job Summary
Seeking a Sr. Manufacturing Engineer with expertise in process validation, equipment qualification, and medical device manufacturing to support automated assembly and packaging operations.
Key Responsibilities
- Lead IQ, OQ, PQ, FAT, and process validation activities.
- Support automated manufacturing equipment through troubleshooting and process optimization.
- Execute process characterization, DOE (Minitab preferred), and statistical analysis.
- Develop SOPs, validation protocols, and manage engineering change controls.
- Lead CAPA, NCR investigations, and root cause analysis.
- Improve Overall Equipment Effectiveness (OEE).
- Support cross-functional manufacturing, quality, and validation activities.
Required Qualifications
- Bachelor's degree in Mechanical, Manufacturing, Mechatronics, Electromechanical, or Electrical/Controls Engineering.
- 4+ years of Manufacturing Engineering experience.
- Strong experience with IQ, OQ, PQ, process validation, and equipment qualification.
- Knowledge of the complete process validation lifecycle.
- Experience with DOE (Minitab preferred), SOP development, CAPA, and change control.
Preferred Qualifications
- Medical device manufacturing experience.
- Knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601, and EU MDR.
- Computer System Validation (CSV).
- Automated assembly and packaging equipment experience.
Thanks & Regards,
Purnasree.U
Recruiter
Intellectt Inc
Purnasree.u@intellectt.com
Desk number: 7324568346 EXT: 234