NPI Project Manager

About the role

We are seeking an experienced NPI Project Manager to lead technical and manufacturing projects in a regulated medical device environment in Costa Rica. The role covers the full project lifecycle from planning through execution and closure, ensuring compliance, timelines, budgets, and stakeholder expectations are met.

Key responsibilities

• Lead planning, coordination, execution, and closure of assigned projects.
• Manage timelines, milestones, risks, resources, budgets, and deliverables.
• Coordinate cross‑functional teams including Engineering, Quality, Manufacturing, Supply Chain and external stakeholders.
• Support new product introduction, product transfers, process development and manufacturing readiness.
• Act as primary contact for projects, including direct customer interaction when required.
• Maintain project documentation, validations, compliance records and project data.
• Identify risks, issues and scope changes, and develop mitigation plans.
• Communicate status, risks and progress to leadership, customers and project teams.

Required profile

• Licentiate degree in Engineering.
• Minimum 5 years of engineering experience in a medical device manufacturing environment.
• Experience with Class II and Class III medical devices.
• Knowledge of ISO 13485 and/or FDA Quality System Regulations.
• Strong project management, leadership, organization and problem‑solving abilities.
• Excellent written and verbal communication skills in English.

Required skills

• Microsoft Project
• Microsoft Office
• Minitab
• CAD software
• ISO 13485
• FDA Quality System Regulations