Manufacturing Engineer II

About the role

A Manufacturing Engineer II is sought to support manufacturing operations, process development and the startup of a new manufacturing facility. The position is on-site in Cartago, Costa Rica, under an indefinite contract, and requires English at B2 level or above.

Key responsibilities

• Develop, improve and qualify manufacturing processes.
• Support equipment installation, commissioning and process validations (IQ/OQ/PQ).
• Develop process flow charts, pFMEAs and manufacturing work instructions.
• Implement Lean Manufacturing methods such as 5S, TPM and Value Stream Mapping.
• Identify process improvements to raise efficiency and productivity.
• Investigate non-conformances, support CAPAs and implement corrective actions.
• Coordinate equipment installation, supplier activities and operator training.
• Collaborate with Engineering, Manufacturing, Quality and Regulatory teams.

Required profile

• Bachelor's degree in Electromechanical, Mechanical, Industrial Engineering or a related field.
• At least 3 years of experience in Manufacturing Engineering.
• Experience in medical device manufacturing and in manufacturing startups, process transfers and process development.
• Hands-on experience with IQ/OQ/PQ validations.
• Knowledge of Lean Manufacturing and continuous improvement.
• Strong problem-solving and technical documentation skills; English B2 or above.
• Availability to work on-site in Cartago.

Required skills

• Proficiency in Microsoft Office, Microsoft Project, Visio and ERP systems.
• Preferred: experience in regulated manufacturing (medical device, pharmaceutical), ERP systems such as Oracle or Acumatica, and processes such as injection molding, soldering, crimping and electrical/mechanical testing.