Manufacturing Engineer I
About The Position
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.
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.
Nice To Haves
- 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.
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
