Manufacturing Engineer II

Medial Group; Villalba (PR); On-site; USD 60,000 - 80,000; Full time

Job summary

Medial Group in Villalba, Puerto Rico seeks a manufacturing engineer with 2+ years of experience to design and optimize production processes, layouts, and procedures for assemblies, equipment installation, processing, and material handling.

You will work on process validation, IQ, CSV, root-cause analysis, SPC, and cross-functional collaboration, with 100% on-site work in Villalba and bilingual English/Spanish communication.

Qualifications

• Experience with process validation, IQ and software validation.
• Ability to perform investigations and root-cause analysis.
• Familiarity with statistical techniques and process control.
• Strong technical writing and bilingual communication (English/Spanish).
• Excellent schedule and deadline management.
• Collaborative cross-functional problem-solving.

Responsibilities

• Design manufacturing processes, procedures, and layouts for assemblies, equipment installation, processing, and material handling.
• Arrange machines within plant facilities for efficient layouts.
• Define operation sequences and procedures for tool and equipment fabrication.
• Adapt machine/equipment design to production conditions.
• Incorporate inspection/test requirements into production plans.
• Inspect machinery and tools to ensure efficiency and quality; initiate corrective actions.
• Develop processes suitable for SPC and related techniques.
• Guide engineering on design concepts to optimize use of equipment and techniques.
• Ensure compliance with applicable regulations.
• Provide technical and sustaining engineering support in manufacturing.
• Conduct investigations and root-cause analyses to improve processes.
• Apply process validation, Equipment IQ, and CSV knowledge for compliance.
• Use statistics to analyze process performance and improve efficiency.
• Manage schedules to meet project deadlines.
• Demonstrate strong technical writing and bilingual communication.
• Work independently on moderately complex projects and cross-functional assignments.
• Collaborate with stakeholders for informed decision-making.

Skills

Process Validation

Equipment IQ

Software Validation

Root Cause Analysis

Statistical QC

Bilingual ENG/ES

Project Scheduling

Job description

Villalba, Puerto Rico

Responsibilities may include the following and other duties may be assigned:

Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.

Design arrangement of machines within plant facilities to ensure the most efficient and productive layout.

Design sequence of operations and specify procedures for the fabrication of tools, equipment, and other functions that affect product performance.

Adapt machine or equipment design to factory and production conditions.

Incorporate inspection and test requirements into the production plan as needed.

Inspect performance of machinery, equipment, and tools to verify their efficiency and initiate corrective actions for problems and deficiencies to ensure product quality.

Develop manufacturing processes that are applicable to statistical process control and may develop those techniques.

Provide guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.

Ensure that processes and procedures are in compliance with applicable regulations.

Provide technical and sustaining engineering support in a manufacturing area.

Perform investigations and root cause analyses to solve problems or improve effectiveness of the job area.

Apply knowledge in Process Validation, Equipment IQ, and Computer Software Validation to ensure compliance and product quality.

Use statistical techniques to analyze process performance and improve efficiency.

Manage schedules and assignments to meet project deadlines without delays.

Demonstrate strong technical writing and communication skills in both English and Spanish to ensure productive collaboration within cross-functional teams.

Work independently with general supervision on moderately complex projects and cross-functional assignments.

Collaborate with other stakeholders to share information, provide updates, and support effective decision‑making.

Requirements

Experience: Minimum of 2 years of relevant experience.

Key Skills and Knowledge:

• Process Validation, Equipment IQ, and Computer Software Validation.
• Investigation and root cause analysis.
• Statistical techniques and process control.
• Technical writing and bilingual communication (English/Spanish).
• Schedule and deadline management.
• Cross-functional collaboration and problem-solving.
• *Willing to work 100% On‑site in Villalba, PR.*