Manufacturing Engineer – Plastic Catheters

Job Overview:

We are seeking an experienced Manufacturing Engineer specializing in plastic catheters to join our dynamic team. The ideal candidate will have extensive knowledge in catheter production processes, materials, and design optimization to enhance manufacturing efficiency and quality. You will play a key role in scaling up production, solving technical challenges, and ensuring compliance with industry standards.

Key Responsibilities:

• Lead and manage the development and optimization of plastic catheter manufacturing processes, ensuring high-quality production.
• Design and implement process improvements to enhance productivity and reduce waste in catheter production lines.
• Collaborate with the R&D team to transition catheter designs from prototype to large-scale production.
• Perform troubleshooting and root-cause analysis of production issues, implementing solutions to improve efficiency.
• Ensure compliance with medical device regulations (ISO 13485, FDA standards).
• Utilize process validation and statistical tools to ensure consistent product quality.
• Manage production timelines, resources, and costs to meet project deadlines.
• Develop and document standard operating procedures (SOPs) for new and existing processes.

Qualifications:

• Bachelor’s degree in Mechanical, Biomedical, or Manufacturing Engineering or related field.
• 3 years of experience in the manufacturing of plastic medical devices, specifically catheters.
• Strong knowledge of thermoplastics, injection molding, and extrusion techniques used in catheter manufacturing.
• Proficient in CAD software (e.g., SolidWorks) and statistical analysis tools.
• Experience with lean manufacturing and six sigma methodologies is a plus.
• Familiarity with ISO 13485, GMP, and FDA 21 CFR Part 820.
• Excellent problem-solving, communication, and project management skills.

Contact me for more details sharief.aksa@tanuinfotech.com

Apply Today!