Senior Medical Device Manufacturing Engineer — Process & Equipment

FITS LLC; Juncos (PR); On-site; USD 75,000 - 105,000; Full time

Job summary

FITS LLC in the Manufacturing sector seeks an experienced engineer to design manufacturing processes, layouts, and equipment strategies. You will lead PLCs of equipment moves, installations, and decommissioning while ensuring GMP compliance and robust change control.

Strong collaboration with teams and bilingual communication are essential. This role requires a mechanical/engineering degree and 5 years in medical devices, with process validation and cleanroom qualification expertise.

Qualifications

• Bachelor’s degree in mechanical engineering with 5 years in medical devices.
• Excellent teamwork skills and collaboration.
• 1st shift with flexibility to business needs.
• Experience with equipment relocation, installation and decommissioning.
• Process validation experience.
• Manufacturing process & facility change management.

Responsibilities

• Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
• Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
• Designs sequence of operations and specifies procedures for fabrication of tools and equipment.
• Adapts machine or equipment design to factory and production conditions; may include inspection and test requirements.
• Inspects performance of machinery, equipment and tools to verify efficiency and initiates corrective action for quality.
• Develops manufacturing processes applicable to statistical process control; may develop those techniques.
• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment.
• Ensures processes and procedures are in compliance with regulations.
• Experience executing manufacturing equipment moves, installations, commissioning, startup and decommissioning.
• Knowledge of facility utilities, equipment integration, and manufacturing readiness activities.
• Strong experience with IQ/CSV/OQ/PQ, process validation, cleaning validation, and cleanroom qualification.
• Familiarity with GMP requirements, change control, risk assessments, and maintaining validated state after equipment or facility changes.
• Experience supporting manufacturing layout changes, facility modifications, material and personnel flow assessments.
• Ability to evaluate facility, utility, and environmental requirements for regulated manufacturing operations.

Skills

Bilingual Spanish-English

Teamwork

Education

Bachelor’s Degree in Mechanical or Engineering

Job description

FITS LLC in the Manufacturing sector seeks an experienced engineer to design manufacturing processes, layouts, and equipment strategies. You will lead PLCs of equipment moves, installations, and decommissioning while ensuring GMP compliance and robust change control.

Strong collaboration with teams and bilingual communication are essential. This role requires a mechanical/engineering degree and 5 years in medical devices, with process validation and cleanroom qualification expertise.