About the Company: CODAN US Corporation is part of the European-based CODAN Group of Companies , which for more than 50 years has been a market leader in the area of IV drug delivery systems to healthcare institutions around the world. From the beginning, CODAN US Corporation's 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 US Corporation 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 to the patients and caregivers whom they serve.

About the Role: CODAN US Corporation , a world-renowned IV therapy product manufacturer is looking for a Production Engineer . The primary responsibilities of a Production Engineer include reviewing the procedures and equipment involved in the manufacturing process. Keeping abreast of advancements in engineering and production, implementing process improvements to maximize efficiency, eliminate waste, and assist in product configurations and validation.

Duties and Responsibilities

• Design efficient work processes and workflow
• Create and maintain DHF, process new products, DMR, quote packets, and samples by Sales and Marketing Department, which include drawings, routing 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
• Perform validation on components, processes, and develop protocols.
• Production team training and support
• Solve and troubleshoot manufacturing issues.
• Work closely with quality teams, perform complaint analysis, and corrective actions.
• Identify issues in efficiency and suggest improvement.
• Analyze products for cost reduction and process optimization
• Perform other duties as assigned.

Requirements

• Bachelor’s degree in engineering (Mechanical, Industrial, or Manufacturing Engineering) required
• Minimum of 5+ years working in an engineering environment preferably for the medical device industry.
• Knowledge of time studies, production process, 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 is a plus
• Great attention to detail and organizational skills
• Analytical, problem-solving, and critical thinking skills to drive process improvements
• Excellent written and oral communication skills.
• Ability to speak Spanish is a plus