Engineering Project Manager

Base pay range

$90,000.00/yr - $/yr

CODAN, a world-renowned IV therapy product manufacturer, is seeking an experienced Engineering Project Manager to plan, coordinate, and manage engineering projects across multiple geographic locations. This role is responsible for ensuring the structured execution of engineering initiatives, including process validations, new product development, automation projects, Methods and Time Studies, BOM and routing updates, ECO implementation, and production support activities. The Engineering Project Manager will lead cross‑functional teams to deliver projects on time, within scope, and within budget while maintaining compliance with regulatory and quality standards.

About the Company

CODAN US Corporation is part of the European-based CODAN Group of Companies. For more than 50 years, CODAN has been a global market leader in IV drug delivery systems serving healthcare institutions worldwide. From the beginning, CODAN’s manufacturing standards have been rooted in a strong commitment to quality patient care. Today, we work closely with clinical practitioners to advance innovative clinical applications and new product development.

Our Commitment

The vital elements that enable CODAN to achieve its mission are strong relationships with leaders in the medical community, a talented and dedicated workforce, and a deep sense of responsibility to our customers and to the patients and caregivers they serve.

Duties and Responsibilities

• Manage and coordinate engineering projects from initiation through completion, including scope definition, scheduling, resource planning, and deadline tracking
• Lead cross-functional project teams to ensure alignment on priorities, deliverables, and timelines
• Coordinate and track process validations (IQ/OQ/PQ), ensuring proper documentation, risk assessments, and approvals
• Support the planning and execution of Methods and Time Studies, including scheduling and resource coordination
• Manage timelines and deliverables for new product development, component qualifications, and engineering improvements
• Coordinate the development, implementation, and continuous improvement of automation projects
• Ensure timely and accurate completion of BOM revisions, routing updates, and new product configurations
• Oversee the Engineering Change Order (ECO) lifecycle, ensuring controlled implementation and clear communication to impacted departments
• Support development and maintenance of component and product specifications through coordinated reviews and document control
• Coordinate cross-functional efforts related to Device History Records (DHR), material requirements, and production readiness
• Track and report project status, risks, and mitigation plans to leadership, proactively identifying potential delays or constraints
• Facilitate collaboration between Engineering, Quality, Regulatory, Manufacturing, Maintenance, Sales, and Marketing teams
• Prepare and maintain comprehensive project documentation, including schedules, status reports, meeting minutes, action items, and communication logs
• Support project execution across U.S. and Mexico manufacturing sites, including travel planning and cross-border coordination
• Perform other project management duties as assigned

Requirements

• Bachelor’s degree in Engineering, Project Management, or a related technical discipline
• Minimum 3 to 5 years of project management experience in a manufacturing environment within the medical device or other regulated industry
• Working knowledge of process validations (IQ/OQ/PQ), FDA regulations, Good Manufacturing Practices (GMP), ISO standards, automation, and product development
• Strong understanding of manufacturing operations and cross-functional business support
• Demonstrated ability to manage multiple engineering projects simultaneously
• Excellent interpersonal, written, and verbal communication skills
• Experience working cross-functionally and coordinating with external vendors
• Knowledge of current ISO 13485 requirements
• Ability and willingness to travel regularly to the Tijuana manufacturing facility

Not Applicable

Full-time

Project Management and Information Technology

Medical Equipment Manufacturing

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