Sr. Manufacturing Engineer

Hello,
My name is Bipasa, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Sr. Manufacturing Engineer based in North Haven, CT 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 bipasa.s@intellectt.com

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.

Job Title: Sr. Manufacturing Engineer
Location: North Haven, CT (Onsite)

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.

Bipasa Swain
Sourcing Specialist
7329976610 | Ext: 300
bipasa.s@intellectt.com