CR-Project Manager I in Alajuela, Alajuela at Theragenics Corp
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Job Description
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.