CR-Project Manager I

Location: Alajuela, Costa Rica Onsite position About The Role We are seeking an NPI Project Manager with a strong foundation in medical device engineering and manufacturing to lead projects focused on the implementation of new manufacturing processes. This is a customer facing role, which is responsible for managing projects from customer engagement through initial production, ensuring successful execution, technical rigor, and regulatory compliance.

This position serves as a technical lead, actively contributing to engineering decisions, process development, and problem-solving while coordinating cross-functional teams and managing customer expectations.

What You’ll Do Project Management & Technical Leadership

• Lead full project lifecycle from customer engagement through initial production, ensuring alignment of all project objectives.
• Act as a hands-on technical lead, directly contributing to manufacturing strategy, and issue resolution.
• Develop and maintain detailed project plans, schedules, and risk mitigation strategies.
• Drive execution by actively engaging with teams to remove technical and operational roadblocks.
• Manage and track critical activities with direct involvement in key technical deliverables.
• Proactively identify and resolve issues that impact timeline, cost, or manufacturability.
• Serve as the primary technical point of contact for customers.
• Lead technical discussions, provide updates, and resolve design or process-related challenges.

Manufacturing Process Development & Implementation

• Translate product requirements into actionable manufacturing plans.
• Evaluate designs, materials, and processes to ensure manufacturability, scalability, and compliance.
• Lead development of new manufacturing processes, including tooling and production workflows.
• Lead or actively contribute to process validation activities (IQ/OQ/PQ) and ensure production readiness.
• Ensure all technical requirements are clearly defined and implemented.

Required Qualifications

• Bachelor’s Degree in Engineering required. Mechanical preferred.

• Minimum 3–5 years of hands-on experience as Senior engineer in R&D, Process Development or Manufacturing medical device or regulated manufacturing environments is a must.

• 1–2 years of project management experience in a cross-functional environment.

• Demonstrated experience in process development, NPI, or manufacturing implementation.

• Ability to work independently on technical challenges.

• Strong understanding of:

• Process validation (IQ/OQ/PQ)

• Medical device quality systems

• Design for Manufacturability (DFM)

Additional Qualifications

• PMP certification preferred.
• Experience in medical device or contract manufacturing environments.
• Experience with project tracking tools (MS Project, Smartsheet, etc.).
• Familiarity with LEAN manufacturing and continuous improvement tools.

Desired Skills

• Hands-on technical problem solving.
• Strong ownership and accountability.
• Ability to balance technical detail with project execution.
• Effective communication with both internal and external stakeholders.

Travel Requirements

• Up to 10% travel.