Automated Assembly Equipment, Change Control, Code of Federal Regulations, Computer Systems, Control Engineering, Corrective and Preventative Action (CAPA) Systems, Electrical Engineering, Electromechanics, Equipment Validation, FDA (Food and Drug Administration), ISO (International Organization for Standardization), International Electro-Technical Commission (IEC), Manufacturing, Manufacturing Engineering, Manufacturing/Industrial Processes, Medical Equipment, Minitab, Process Improvement, Process Validation, Root Cause Analysis, Standard Operating Procedures (SOP), Statistics, System Validation, United States Department of Energy (DOE), Validation Documentation
Hello,
I hope you're doing well.
My name is Mahalakshmi, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Sr. 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
mahalakshmi.n@intellectt.com
OR +1 (732) 737 8381
Job Title: Sr. Manufacturing Engineer
Location: North Haven, CT (Onsite)Job Description:
We are seeking a Sr. Manufacturing Engineer with 4+ years of experience in manufacturing engineering within a regulated environment. The ideal candidate will have strong expertise in process validation, equipment qualification, automated manufacturing, and continuous process improvement.
Required Skills:
- IQ, OQ, PQ, FAT & Process Validation
- Equipment Qualification & Process Characterization
- DOE (Minitab), Statistical Analysis
- CAPA, NCR, Root Cause Analysis & Change Control
- SOP Development & Validation Documentation
- Automated Assembly & Packaging Equipment
- OEE Improvement & Manufacturing Process Optimization
Preferred:
- Medical Device Manufacturing
- FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601 & EU MDR
- Computer System Validation (CSV)
Education: Bachelor's degree in Mechanical, Manufacturing, Mechatronics, Electromechanical, or Electrical/Controls Engineering.
Thanks & Regards,
Mahalakshmi
Junior Recruiter
Intellectt Inc
mahalakshmi.n@intellectt.com
Direct: +1 (732) 737 8381