Manufacturing Engineer

About the role

The Manufacturing Engineer will provide technical support and drive process improvements to reduce costs while ensuring high‑quality production of medical‑technology products. This role involves designing tools and machines, solving production challenges, and implementing new technologies across the Humacao facility.

Key responsibilities

• Design, approve, and build complex tooling and equipment for product manufacturing.
• Develop, document, and validate processes, methods, and production controls for new programs.
• Set up and commission new equipment, write operating procedures, and train users.
• Lead technology transfers, optimize material flow, and introduce lean concepts.
• Manage validation protocols (IQ, OQ, PQ) and ensure compliance with cGMP, OSHA, and ISO 9000 standards.
• Plan and execute capital equipment projects, including budgeting and justification.

Required profile

• Bachelor’s degree in Mechanical, Industrial, or Chemical Engineering.
• 2‑5 years of manufacturing experience, preferably with tool and machine design.
• Fully bilingual in English and Spanish with strong written and oral communication.
• Knowledge of cGMP, OSHA, ISO 9000, and continuous process improvement techniques.

Required skills

• Tool and machine design.
• Packaging methods: heat sealing, thermoforming, thermoplastic.
• Statistical Process Control (SPC) and Design of Experiments.
• Six Sigma Black Belt (highly desirable).
• Project management tools.
• Validation protocols: Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ).