Manufacturing Engineer

Job Description

MANFACTURING ENGINEER II (12-MONTH CONTRACT NO C2C, W2 ONLY)

Location : North Haven, CT

About the Role :

We are seeking a Manufacturing Engineer II for a consulting / contract assignment with a leading medical device company. In this role, you’ll work on-site supporting manufacturing operations, optimizing packaging and assembly lines, executing validations, and ensuring compliance with regulatory standards — all while providing your engineering expertise as a contractor.

Key Responsibilities :

• Support day-to-day manufacturing operations at the client site, resolving line downtimes, scrap issues, and equipment challenges.
• Conduct root cause investigations for nonconformances and implement corrective actions.
• Execute equipment and process validation protocols (IQ / OQ / PQ) .
• Design and optimize manufacturing processes, equipment layouts, and production sequences.
• Maintain technical documentation, SOPs, and batch records for regulatory compliance.
• Collaborate with cross-functional teams, including Quality, R&D, and Supply Chain, while acting as the engineering consultant on-site.
• Ensure compliance with FDA, ISO 13485, and cGMP standards.

Requirements :