Apply on Employer Site

CODAN US Corporation · 1 day ago

Design Engineer

Orange County, CA

Full-time

Onsite

Senior Level

$70K/yr - $90K/yr

5+ years exp

CODAN US Corporation is a world-renowned IV therapy product manufacturer seeking a Design Engineer. The primary responsibilities of this role include designing, developing, and improving products to meet customer and business needs, while ensuring compliance with industry standards and collaborating with cross-functional teams.

Health CareManufacturingMedical Device

Hiring Manager

Maria Martinez

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 validation of 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

Qualification

SolidWorksAutoCADDHF knowledgeGMP knowledgeISO9000 knowledgeISO13485 knowledgeValue Stream mappingKaizenD365 dynamicsAnalytical skillsAttention to detailOrganizational skillsProblem-solving skillsCritical thinking skillsWritten communicationOral communication

Required

Bachelor's Degree in Engineering (Mechanical, Industrial, or Manufacturing Engineering)

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

Great attention to detail and organizational skills

Analytical, problem-solving, critical thinking skills to drive process improvements

Excellent written and oral communication skills