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.