Manufacturing Engineer for Medical Devices & Reliability

FITS LLC; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

FITS LLC in Puerto Rico seeks an engineering professional to support manufacturing services for the Medical Devices and Pharmaceutical sector. You will evaluate technical problems, apply standard engineering methods, and act as a technical expert to assist in troubleshooting across multiple departments.

The role emphasizes reliability, change control, CAPAs, and achieving equipment performance metrics while collaborating with maintenance, utilities, and QA teams to meet schedules and quality

Qualifications

• Bachelor’s degree in Engineering and two years of relevant experience in Medical Devices or Pharmaceutical industries.
• Bilingual (Spanish & English).
• Shift: Administrative depending on business needs.
• Experience with Manufacturing Equipment in CMMS systems.
• Reliability and change control assessments and requirements.
• Maintenance strategy for manufacturing equipment operations.
• Develop equipment performance metrics.
• Support deviation processes and define, implement and own CAPAs.

Responsibilities

• Provide solutions to a variety of technical problems of moderate scope and complexity.
• Under general supervision evaluate, select and apply standard engineering techniques and procedures.
• Function as a technical expert in process, equipment and systems during troubleshooting operations and cross-functional discussions.
• Actively participate in daily operations to meet schedules or resolve complex problems.
• Routinely supervise manufacturing processes for performance indicators and operations; suggest resolutions and provide troubleshooting mentorship.
• Collaborate with manufacturing, maintenance, process development, utilities, facilities, quality assurance and validation departments on process/system modifications.
• Support manufacturing/quality systems such as deviations, equipment qualification and process validation, procedures, training, and new product introductions.
• Apply engineering principles to design and implement system modifications, experiments and capital projects.

Skills

Bilingual Spanish & English

Proactive and task-oriented

Customer service oriented

Problem solving

Education

Bachelor’s degree in Engineering

Tools

CMMS system

Job description

FITS LLC in Puerto Rico seeks an engineering professional to support manufacturing services for the Medical Devices and Pharmaceutical sector. You will evaluate technical problems, apply standard engineering methods, and act as a technical expert to assist in troubleshooting across multiple departments.

The role emphasizes reliability, change control, CAPAs, and achieving equipment performance metrics while collaborating with maintenance, utilities, and QA teams to meet schedules and quality