MES Engineer

Real; San Jose (CA); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Health benefits

Dental benefits

Vision benefits

401K enrollment

13 days of PTO

9 paid holidays

Job summary

Real is looking for a MES Engineer based in San Jose, California, to design and implement electronic production workflows. This position involves optimizing manufacturing processes and ensuring compliance with FDA regulations in a regulated medical device environment.

The ideal candidate will have experience in analyzing Manufacturing Process Instructions and Technical Process Instructions, collaborating with cross-functional teams, and facilitating end-user training. The contract offers benefits like health, dental, vision, and 401K options, along with generous vacation time.

Qualifications

• Experience as a MES Engineer in a regulated medical device environment.
• Strong skills in analyzing manufacturing process documents.
• Ability to ensure compliance with FDA regulations and ISO standards.

Responsibilities

• Design and implement MES workflows to optimize manufacturing processes.
• Analyze MPIs and TPIs for accurate system configuration.
• Collaborate with teams to resolve technical issues.
• Conduct audits and support validation activities.
• Facilitate end-user training on MES applications.

Skills

Design and implement electronic production workflows

Manufacturing Process Instructions (MPIs)

Technical Process Instructions (TPIs)

FDA regulations compliance

Collaboration with cross-functional teams

SQL for data collection

User Acceptance Testing (UAT)

Job description

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.