Job Description

CODAN US Corporation, a world-renowned IV therapy product manufacturer is looking for a Design Engineer . The primary responsibilities of a Design Engineer include, but are not limited designing, developing, and improving products to meet customer and business needs. This role requires strong technical expertise to design new products, enhance existing designs, and ensure manufacturability, cost efficiency, and compliance with industry standards. The ideal candidate should be creative, detail-oriented, and highly collaborative, working with cross-functional teams to drive projects from concept to production.

Job Location: This position requires the employee to work at our office in Santa Ana (Orange County), CA. There is not an option for remote work.

About the Company:

CODAN US Corporation is part of the European-based CODAN Group of Companies, which has been a market leader in IV drug delivery systems to healthcare institutions around the world for more than 50 years. From the beginning, CODAN product manufacturing standards have been based on a singular dedication to quality patient care. Today, we work closely with clinical practitioners to maintain our commitment to innovative clinical applications and new product development.

Our Commitment:

The vital elements that enable CODAN to achieve its mission are our relationships with leaders in the medical community, our talented, trained, and committed employees, and our sense of responsibility to our customers and the patients and caregivers they serve.

Duties and Responsibilities

• Design and develop new products and components, ensuring compliance with industry

standards and company requirements

• Conduct research, feasibility studies, and engineering analysis to support design concepts
• Perform testing, develop protocols, and validate designs to ensure performance and reliability.
• Support prototyping, product testing, and troubleshooting of design issues
• Maintain technical documentation, including design reports, test plans, and regulatory compliance records.
• Assist in continuous improvement initiatives and product lifecycle management.
• Create and maintain DHF, process new products, DMR, quote packets, and samples
• requested by Sales and Marketing Department, which include drawings, routing
• operations, labels, and material requirements for the assembly of all products.
• Collaborate with cross-functional teams to develop efficient Engineering and
• manufacturing process and ensure that production processes meet quality standards.
• Generate process documentation, standard operating procedures (SOP), and reports
• Develop and update specifications for parts used in the manufacture of I.V. sets, OEM
• medical devices, and chemotherapy protective equipment.
• Identify and resolve manufacturing issues, ensuring efficiency and product reliability.
• Perform complaint analysis, and corrective actions to address product-related concerns.
• Identify areas for efficiency improvements and suggest process optimizations.
• Analyze products for cost reduction opportunities and workflow enhancements.
• Perform other duties as assigned.

Requirements

• Bachelor’s Degree in Engineering (Mechanical, Industrial, or Manufacturing Engineering) advanced degrees can be an advantage.
• Minimum of 5+ years working in an engineering environment, preferably for the Health Care Industry
• Knowledge of DHF (Design History File), MRP (particularly Bills of Materials), cost reductions, product development and qualification, and Good Manufacturing Practices (GMP’s).
• Knowledge of standards such as ISO9000 & ISO13485
• Value Stream mapping and Kaizen
• Experience with SolidWorks and/or AutoCAD
• Knowledge of D365 Dynamics preferred
• Great attention to detail and organizational skills
• Analytical, problem-solving, critical thinking skills to drive process improvements
• Excellent written and oral communication skills.

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