Sr. Manufacturing Engineering

Intellectt INC

North Haven, CT
2 days ago

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Skills

Automated Assembly Equipmentunmatched
Change Controlunmatched
Code of Federal Regulationsunmatched
Computer Systemsunmatched
Continuous Improvementunmatched
Control Engineeringunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
Electricityunmatched
Electromechanicsunmatched
Engineeringunmatched
Equipment Validationunmatched
Experiment Designunmatched
FDA (Food and Drug Administration)unmatched
ISO (International Organization for Standardization)unmatched
Identify Issuesunmatched
International Electro-Technical Commission (IEC)unmatched
Manufacturingunmatched
Manufacturing Assemblyunmatched
Manufacturing Engineeringunmatched
Manufacturing Equipmentunmatched
Medical Equipmentunmatched
Microsoft Excelunmatched
Microsoft Officeunmatched
Microsoft PowerPointunmatched
Microsoft Wordunmatched
Minitabunmatched
Process Improvementunmatched
Process Validationunmatched
Root Cause Analysisunmatched
Standard Operating Procedures (SOP)unmatched
System Validationunmatched
Team Playerunmatched
United States Department of Energy (DOE)unmatched

Description

Hi ,

Hope you are doing good,

My name is Ayaan, and I'm a Senior Recruiter at Intellectt Inc. I came across your profile and believe your experience could be a good match for an exciting opportunity

I'm currently working on.

If you're interested, please send your updated resume to ayaan.f@intellectt.com

Title: Sr. Manufacturing Engineer
Location: North Haven, CT
Duration: Long Term

Job Summary
We are looking for a Manufacturing Engineer with experience in Medical Device manufacturing, equipment qualification, and process validation to support manufacturing, assembly, and packaging operations.

The ideal candidate should have hands-on experience with validation activities, process improvements, and automated manufacturing equipment.

Required Skills
Bachelor's degree in Mechanical, Mechatronics, Electromechanical, Electrical, or Controls Engineering.
4+ years of Manufacturing Engineering experience.
Hands-on experience with IQ, OQ, PQ (Equipment Qualification).
Experience with the Process Validation Lifecycle (Process Characterization, OQ, PQ).
Process improvement and Root Cause Analysis (5 Why, 6M, CAPA).
Experience supporting automated manufacturing/assembly equipment.
SOP development and Change Control.
Strong troubleshooting and cross-functional collaboration skills.

Preferred Skills
Design of Experiments (DOE) using Minitab.
Computer System Validation (CSV).
Custom equipment and packaging equipment validation.
Medical Device industry experience.
Knowledge of FDA 21 CFR Part 820, EU MDR 2017/745, ISO 13485, ISO 14971, and IEC 60601.
Experience with absorbable/non-absorbable sutures is a plus.
Proficiency with Microsoft Office (Excel, Word, PowerPoint).
This role is ideal for a Manufacturing Engineer with strong equipment qualification, process validation, troubleshooting, and continuous improvement experience in a regulated Medical Device manufacturing environment.