Manufacturing Engineer I (Entry Level)

CIS International

Juncos, Puerto Rico

JOB DETAILS
SKILLS
Analysis Skills, Biotech and Pharmaceutical, Budgeting, Communication Skills, Computer Skills, Computer Systems, Continuous Improvement, Corrective Action, Cross-Functional, Detail Oriented, Electricity, English Language, FDA (Food and Drug Administration), Failure Mode and Effects Analysis (FMEA), GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Machining, Maintain Compliance, Manufacturing, Manufacturing Assembly, Manufacturing Engineering, Manufacturing Execution Systems (MES), Manufacturing Requirements, Manufacturing/Industrial Processes, Mechanical Engineering, Medical Equipment, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Microsoft Word, Minitab, Multilingual, Operational Improvement, Operational Strategy, Organizational Skills, Problem Solving Skills, Process Validation, Productivity Management, Professional Services, Public/Media/Press/Analyst Relations, Regulations, Research & Development (R&D), Risk Management, Spanish Language, Statistical Process Control, System Validation, Technical Writing, Test Requirements, Time Management, Writing Skills
LOCATION
Juncos, Puerto Rico
POSTED
30+ days ago

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

About the Company

C

CIS International