Manufacturing Engineer I

Medial Group; Puerto Rico; On-site; USD 75,000 - 95,000; Full time

Job summary

Medial Group in Villalba, Puerto Rico, seeks a Manufacturing Engineer I to support the FACTORYworks Pulse project by performing Computer Software Validation (CSV) for manufacturing software and computer systems in regulated environments.

You will develop validation protocols, run tests, document results, and assist EC/EF implementations under Global IT MSCM and local CSV rules. Collaboration with engineering and operations is essential to minimize production disruption.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Electrical, Computer, Chemical, Industrial or related).
• Minimum 3 years in regulated industries supporting software and computer system validations, including protocol development and documentation.

Responsibilities

• Execute CSV activities for software and computer equipment supporting FACTORYworks Pulse.
• Develop, execute, and document validation protocols, tests, and summary reports.
• Support EC and EF validation activities under Global IT MSCM and local CSV requirements.
• Perform IQ-type activities and assist protocol approvals prior to software deployment.
• Investigate, troubleshoot, and perform root cause analysis related to software performance and validation.

Skills

CSV

Validation protocols

IQ/OQ/PQ

Regulatory compliance

Technical writing

Bilingual EN/ES

Education

Bachelor’s degree in Engineering

Tools

MES systems

FW Pulse

Windows 10/11

Job description

Villalba, Puerto Rico | Posted on 04/06/2026

The Manufacturing Engineer I will support the FACTORYworks (FW) Pulse project by executing Computer Software Validation (CSV) activities for manufacturing software and computer systems used in regulated production environments. This role is responsible for developing and executing validation protocols, preparing reports, supporting Equipment Controller (EC) and External Functions (EF) implementations, and ensuring compliance with global and local quality requirements. The position collaborates cross-functionally with engineering, operations, and process owners to support software changes without disrupting manufacturing operations.

Responsibilities / Job Roles & Project Goals

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

• Execute Computer Software Validation (CSV) activities for software and computer equipment supporting FACTORYworks Pulse.
• Develop, execute, and document validation protocols, test cases, and summary reports to support software qualification and release to manufacturing.
• Support validation activities related to Equipment Controllers (EC) and External Functions (EF) under Global IT MSCM and local CSV requirements.
• Perform Installation Qualification (IQ)-type activities and support protocol approvals prior to software deployment.
• Conduct investigations, troubleshooting, and root cause analysis related to software performance and validation issues.
• Collaborate with engineering and operations process owners to coordinate maintenance windows and protocol execution.
• Support process validation and computer software validation documentation in compliance with regulated industry requirements.
• Ensure software revisions function equivalently to production versions before release.
• Support software installation and troubleshooting on Windows 10/11 computers and peripheral equipment when needed.
• Participate in project activities following Waterfall or equivalent SDLC methodologies.
• Prepare technical documentation with strong attention to detail and regulatory compliance.
• Support continuous improvement initiatives and validation best practices.

*Other duties may be assigned.*

Requirements

• Bachelor’s degree in Engineering (Mechanical, Electrical, Computer, Chemical, Industrial or related discipline).
• Minimum 3 years of experience in regulated industries (medical device, pharmaceutical, or similar) supporting software and computer system validations, including protocol development, execution, and validation documentation in compliance with quality and regulatory requirements.
• Knowledge of Process Validation, IQ/OQ/PQ principles, and regulated validation requirements.
• Experience with investigation and root cause analysis methodologies.
• Strong technical writing, organizational, and communication skills in English and Spanish.
• Ability to work independently with minimal supervision while collaborating cross-functionally.

Preferred Qualifications

• Previous experience executing Computer Software Validation (CSV) of Equipment Controllers in a Medtronic facility highly desirable.
• Knowledge of FACTORYworks (FW) Pulse, MES systems, Equipment Controllers (EC), or External Functions (EF).
• Experience with Waterfall or equivalent SDLC methodologies.
• Familiarity installing and troubleshooting software and peripheral equipment in Windows 10/11 environments.
• Experience coordinating software releases in manufacturing environments.

Top 3 Candidate Requirements

• Hands-on experience performing software and computer system validations, preferably CSV for Equipment Controllers in a regulated manufacturing environment.
• Strong technical documentation and communication skills, with the ability to develop and execute qualification protocols and reports.
• Ability to work independently while coordinating with engineering and operations teams to execute validation activities successfully.

*Willing to work On-site 100% in Villalba and weekends when needed.*