MES Engineer

We have a current opportunity for a MES Engineer. The position will be based in San Jose. For further information about this position please apply.

Desired Skills and Experience

MES Engineer
Location: San Jose, CA
Duration: 12- Month Initial Contract- multiyear project, plans to extend
Role Offers: health, dental, vision benefits & 401K enrollment options
Vacation Time: 13 days of PTO 9 paid holidays

Overview:
· Design and implement electronic production workflows within MES to optimize manufacturing processes, improve traceability, and enhance overall operational efficiency in a regulated medical device environment.
· Analyze Manufacturing Process Instructions (MPIs) and Technical Process Instructions (TPIs) to ensure accurate system configuration and alignment with engineering specifications, device history records (DHR), and production requirements.
· Collaborate with cross-functional teams including Manufacturing, Quality, Validation, and Engineering to identify, troubleshoot, and resolve technical and process-related issues during system development and deployment.
· Ensure compliance with FDA regulations, ISO standards, and Good Documentation Practices (GDP) by conducting audits, supporting validation activities, and implementing corrective and preventive actions (CAPA).
· Facilitate end-user training sessions on MES applications and updates, improving system adoption, data integrity, and operator efficiency on the production floor.
· Streamline manufacturing data collection and reporting processes using SQL, enabling faster decision-making, improved traceability, and enhanced regulatory reporting capabilities.
Execute User Acceptance Testing (UAT) and supported validation (IQ/OQ/PQ) efforts for MES enhancements and new system implementations, ensuring compliance, system reliability, and high-quality performance for end users.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

To find out more about Real, please visit www.realstaffing.com