Manufacturing Engineer Syringe Production

Job Description:

Role:

A manufacturing engineer in medical syringe production is responsible for ensuring the manufacturing process is efficient, cost-effective, and meets stringent quality and regulatory standards, including FDA and ISO 13485. Key duties include process validation ()), equipment maintenance and calibration, developing SOPs, improving efficiency through methodologies like Lean and Six Sigma, and ensuring adherence to strict hygiene and sterile-handling protocols. This role also involves collaboration with quality assurance, research and development, and vendor management for equipment and components. 

Core responsibilities 

• Process development and validation: implement and validate manufacturing processes for syringes and associated components. This includes equipment installation, calibration, and process optimization using methodologies like Lean manufacturing and Six Sigma.
• Quality and regulatory compliance: maintain quality assurance procedures and control measures in compliance with FDA and ISO 13485 standards. This includes documenting processes, creating Standard Operating Procedures (SOPs), and ensuring Good Manufacturing Practices (GMP) are followed.
• Equipment and tooling: Support the design, selection, and acquisition of new equipment. Assist in the design of fixtures and tooling and oversee the maintenance and calibration of existing machinery.
• Production support and continuous improvement: Provide day-to-day technical support to the production floor, resolve manufacturing issues, and implement continuous improvement plans to increase efficiency and quality.
• Hygiene and sterile control: Enforce and maintain strict hygiene and sterilization protocols throughout the entire manufacturing process, from raw material handling to final packaging, ensuring all sterile conditions are met for plastic syringes and other medical devices.
• Collaboration and documentation: Work cross-functionally with other engineers, quality assurance, and suppliers. Create and maintain essential manufacturing documentation, such as process instructions, router forms, and validation reports. 

Specific to medical syringes 

• Manufacturing process : Hands on experience in Injection Molding machines , packing and assembly machines, ETO equipment , chillers , compressors etc.
• Sterilization methods: Deep knowledge of sterilization methods like ethylene oxide (EtO) sterilization is critical for both the product and its packaging.
• Cleanroom and sterile environment management: Ensure production occurs in a sterile, controlled environment and that all personnel follow strict cleanroom protocols.
• Hygiene during processing: Understand specific handling and hygiene needs for different materials like plastic and maintain strict controls during forming and assembly stages. 

Candidates must have hands on experience in installation and managing the various machinery of manufacturing of medical syringes .

Graduate in engineering or science field with 8-10 years’ experience . Experience in medical syringes manufacturing is preferred

We would like to fill this position latest by Dec 1, 2025.