Senior Manufacturing Engineer - Medical Devices, Bilingual

FITS, LLC; Juncos (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

FITS, LLC in Puerto Rico seeks an experienced Manufacturing Engineer to design and optimize production layouts, equipment installation, and change management for medical devices. You will lead process validation, equipment moves, and qualification activities to ensure product quality and regulatory compliance.

The ideal candidate has a mechanical engineering background, bilingual Spanish/English, and a collaborative mindset to work across teams and sites, while supporting a fast-paced

Qualifications

• Bachelor’s Degree in Mechanical or Engineering and five (5) years of exposure within the Medical Devices Industry.
• Soft Skills: Excellent teamwork skills.
• Shift: 1st, and according to business needs.
• Experience in: Equipment Relocation, Installation & Decommissioning
• ProcessValidation
• 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 the fabrication of tools and equipment and other functions that affect product performance.
• Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan.
• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques.
• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Ensures processes and procedures are in compliance with regulations.
• Experience executing manufacturing equipment moves, installations, commissioning, startup, and decommissioning activities.
• Knowledge of facility utilities, equipment integration, and manufacturing readiness activities.
• Strong experience with equipment qualification (IQ/CSV/OQ/PQ), process validation, cleaning validation, and cleanroom qualification.
• Familiarity with GMP requirements, change control, risk assessments, and maintaining validated state following 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 and English

Teamwork skills

Education

Bachelor’s Degree in Mechanical or Engineering

Job description

FITS, LLC in Puerto Rico seeks an experienced Manufacturing Engineer to design and optimize production layouts, equipment installation, and change management for medical devices. You will lead process validation, equipment moves, and qualification activities to ensure product quality and regulatory compliance.

The ideal candidate has a mechanical engineering background, bilingual Spanish/English, and a collaborative mindset to work across teams and sites, while supporting a fast-paced