Manufacturing Engineer II (Hybrid)

About the role

Theragenics Costa Rica, located in the El Coyol Free Zone of Alajuela, is hiring a Manufacturing Engineer II in a hybrid position. The role supports production troubleshooting, process development and continuous improvement in a highly technical manufacturing environment, working with cross-functional teams.

Key responsibilities

• Support production in troubleshooting process issues and defects, and resolve unplanned downtime caused by equipment failures so production can resume.
• Collaborate with production to investigate root causes, implement corrective actions and develop procedures for product quality and process capability.
• Review documentation procedures for accuracy and upgrades required by change orders, and support the implementation of GMP across the organization.
• Help develop production processes, standard operating procedures and drawings, and train production supervisors, operators and assemblers.
• Create, route and execute engineering reports covering validation phases such as engineering studies, process development, installation, operational and performance qualifications.
• Define manufacturing work instructions, procedures and standard work, and develop work center layouts, time estimates, staffing needs, capacity models and costs.
• Apply Lean Manufacturing, Six Sigma and OpEx back to basics principles, evaluate product flows and identify automation and other technical improvements.
• Manage the installation and performance of new processes and equipment, verify and validate them, and report weekly working hours for process technicians.

Required profile

• Bachelor's degree in Engineering, Manufacturing Engineering or a related field.
• Bilingual English and Spanish.
• 3-5 years of experience in an industrial or manufacturing environment; medical device manufacturing experience highly preferred.
• Experience leading, mentoring or coordinating technical teams is desirable.

Required skills

• Knowledge of GMP and ISO 13485 is a plus.
• Process development, troubleshooting, validation and continuous improvement.
• Familiarity with Lean Manufacturing and Six Sigma.