Manufacturing Engineer Medical Syringes

About the Company

Potential Job Opportunity in East Africa.

About the 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.

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.

Qualifications

• Graduate in engineering or science field with 8-10 years’ experience.
• Candidates must have hands-on experience in installation and managing the various machinery of manufacturing of medical syringes.

Required Skills

• 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.

Preferred Skills

• Experience in medical syringes manufacturing is preferred.

Pay range and compensation package

The maximum budget for this position is a gross salary of $3000 per month (Net salary will be $1650 per month). From the gross salary amount, there will be a NSSF deduction of 20% ($600 per month) and Income tax of $750 per month. The deducted NSSF amount will be reimbursed by NSSF authority to the employee at the end of his service period. So, technically, the employee stands to earn $2250 per month ($1650 net salary that will be paid every month) + $600 (that will be paid as a lump sum upon end of his service period).

Equal Opportunity Statement

We are committed to diversity and inclusivity in our hiring practices.

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