Job Description

Responsibilities may include the following:

• Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, machining, and material handling.
• Develop and optimize workflow and sequence of operations to improve efficiency and productivity.
• Design equipment and facility layouts to maximize production capabilities.
• Adapt machine and equipment designs to meet manufacturing and production requirements.
• Incorporate inspection and testing requirements into production processes.
• Evaluate equipment performance and implement corrective actions to resolve issues.
• Support statistical process control (SPC) and continuous improvement initiatives.
• Provide engineering support for design concepts and manufacturability.
• Ensure compliance with FDA, ISO, and GMP regulations.
• Collaborate with cross-functional teams including Quality, Operations, and R&D.
• *Other duties may be assigned.*

Requirements:

Education and Experience:

• Bachelor’s Degree in Engineering (Mechanical, Electrical, Chemical, or related).
• 0–3 years of experience in manufacturing, engineering, or related roles.
• Bilingual (English & Spanish).
• Experience in Computer System Validation (CSV).
• Experience working in a regulated environment (Medical Devices or Pharmaceutical industry).
• Basic knowledge of manufacturing processes and equipment.
• Strong organizational, communication, and technical writing skills.

Preferred Qualifications:

• Knowledge of Process Validation (IQ/OQ/PQ)
• Experience with Statistical Tools (Minitab or equivalent)
• Familiarity with MES systems (e.g., FactoryWorks)
• Knowledge of risk management tools (FMEA)
• *Willing to work 100% On-Site, weekend and other shifts when necessary.*

Skill set

Systems & Tools:

• Minitab (or equivalent statistical tools)
• Microsoft Office Suite (Excel, Word, PowerPoint)

Soft Skills:

• Bilingual Communication (English & Spanish)
• Problem Solving & Analytical Thinking
• Organization & Time Management
• Team Collaboration
• Attention to Detail

Work Methodology

• 100% on site job in Juncos- PR
• Administrative Shift
• Duration: 6 months (1st contract) with a high possibility of extension based on performance and budget.
• Professional services Contract
• Type of industry: Medical devices