Process Engineer I - Medical Device Manufacturing

FITS LLC; Humacao (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

FITS LLC in Humacao, Puerto Rico, is seeking an engineer with a Bachelor’s in Mechanical, Biomedical, Industrial or Chemical Engineering and 3 years in the Medical Devices Industry. Bilingual in Spanish and English with strong teamwork skills is required.

The role provides technical and sustaining engineering support in a manufacturing area, driving equipment and process improvements, and ensuring regulatory compliance. Availability for administrative shifts per business needs is expected.

Qualifications

• Bachelor’s Degree in Mechanical, Biomedical, Industrial or Chemical Engineering with 3 years of exposure in the Medical Devices Industry.
• Bilingual: Spanish and English.
• Soft skills: Excellent teamwork.
• Shift: Administrative and according to business needs.
• Experience in validations, problem solving, and team-oriented work.

Responsibilities

• Provides technical and sustaining engineering support in a manufacturing area.
• Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies and yields for existing products.
• Integrates equipment and material capabilities to meet target specifications.
• Reviews product development requirements for compatibility with processing methods and costs.
• Interacts with product design and development personnel to ensure compatibility of processes and designs.
• Develops and conducts statistical analyses or adds to documentation.
• Leads innovation and optimization of new manufacturing concepts and processes for transfer to production.
• Includes scoping, material selection, process/equipment selection, tooling/fixtures, and assessment of inputs/outputs.
• Develops manufacturing processes applicable to statistical process control and related measurement systems.
• Ensures processes and procedures comply with regulations.

Job description

FITS LLC in Humacao, Puerto Rico, is seeking an engineer with a Bachelor’s in Mechanical, Biomedical, Industrial or Chemical Engineering and 3 years in the Medical Devices Industry. Bilingual in Spanish and English with strong teamwork skills is required.

The role provides technical and sustaining engineering support in a manufacturing area, driving equipment and process improvements, and ensuring regulatory compliance. Availability for administrative shifts per business needs is expected.