Manufacturing Engineer

Role: Manufacturing Engineer (Training)

Experience Required: 10 + Years

Industry: Medical Devices / Life Sciences

Work Type: Remote

Overview

We are seeking a Manufacturing Engineer who can Train with strong experience in regulated medical device production. The role requires deep understanding of process engineering, equipment qualification, documentation, and compliance with FDA, ISO 13485, and related quality standards. The candidate must be able to support daily operations, resolve technical issues, and improve manufacturing reliability with a practical and disciplined approach.

Key Responsibilities

• Supported manufacturing operations by troubleshooting equipment, process deviations, and quality issues.
• Executed process validations (IQ, OQ, PQ) and prepared complete validation documentation.
• Reviewed and updated manufacturing work instructions, SOPs, PFMEAs, and control plans to ensure compliance with regulatory expectations.
• Drove root cause investigations using structured methods such as 5 Whys and fishbone analysis and implemented corrective and preventive actions.
• Coordinated equipment qualification, calibration needs, and maintenance activities.
• Improved production yields and reduced scrap through disciplined process analysis and data-based decision-making.
• Reviewed engineering change orders (ECOs) and ensured smooth implementation on the shop floor.
• Supported NPI transfers by preparing process documentation, defining process parameters, and stabilizing new production lines.
• Collaborated with Quality, R&D, Supply Chain, and Technicians to maintain robust and compliant operations.
• Ensured adherence to ISO 13485, FDA 21 CFR Part 820, and internal quality systems at all stages of manufacturing.
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