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CODAN US Corporation · 1 day ago

Engineering Project Manager

Orange County, CA

Full-time

Hybrid

Mid, Senior Level

$90K/yr - $110K/yr

3+ years exp

CODAN US Corporation is a global market leader in IV drug delivery systems seeking an experienced Engineering Project Manager to oversee engineering projects across multiple locations. The role involves managing project execution, leading cross-functional teams, and ensuring compliance with regulatory and quality standards.

Health CareManufacturingMedical Device

Hiring Manager

Maria Martinez

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

Qualification

Process ValidationsFDA RegulationsManufacturing PracticesProject ManagementISO StandardsAutomationProduct DevelopmentISO 13485Interpersonal SkillsWritten CommunicationVerbal CommunicationCross-Functional Coordination

Required

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