Manufacturing Engineer

Key Responsibilities:
Support and oversee implant medical device manufacturing lines and systems.
Experience with Orthopedic Implants manufacturing, including Foundry and CNC Milling/Turning.
Implement Design for Manufacturing (DFM) processes and continuous improvement.
Drive daily cleanroom operations with a focus on KPI-driven processes and lean methodologies.
Ensure proper maintenance and calibration of critical equipment and systems.
Handle FDA regulations, ISO standards, and ensure quality control.
🛠 Skills & Experience Required:
6+ years of experience in a machine shop environment.
Expertise in packaging, cleanroom operations, and medical device manufacturing.
Experience with IQ/OQ/PQ validations, quality systems, and regulatory compliance.
Strong knowledge of machining processes, including milling, lathe machines, and additive manufacturing.
Familiarity with FDA regulations and ISO standards like 21 CFR, ISO 11607, and more