Manufacturing Engineer (Medical Devices)

TL;DR

Manufacturing Engineer (Medical Devices): Designing and implementing automated control systems for medical device production with an accent on PLC/HMI programming, process validation, and regulatory compliance. Focus on optimizing manufacturing efficiency, troubleshooting complex control systems, and ensuring adherence to ISO 13485 and FDA standards.

Location: Must be based in Austin, Texas

Company

hirify.global is a global leader in immunodiagnostic and molecular diagnostic solutions, dedicated to improving patient outcomes through scientific innovation.

What you will do

• Design, develop, and implement automated control systems for medical device manufacturing.
• Program and configure PLCs and HMI systems to enhance operational efficiency.
• Collaborate with R&D and Quality Assurance teams to identify and resolve automation needs.
• Ensure full compliance with FDA and ISO 13485 regulatory standards.
• Conduct risk assessments and FMEA to mitigate potential production issues.
• Manage engineering change control and provide training for manufacturing personnel.

Requirements

• Bachelor’s degree in Electrical, Mechanical, or Automation Engineering.
• 2+ years of experience in control/automation engineering within a regulated industry.
• Proficiency in PLC programming and HMI configuration.
• Experience with Python, SQL, and SolidWorks.
• Knowledge of SCADA systems and industrial networks.
• Must be authorized to work in the United States.

Nice to have

• Experience with robotics and motion control systems.
• Certification in Quality Assurance or Six Sigma.
• Familiarity with LabVIEW or MATLAB.

Culture & Benefits

• Competitive salary and comprehensive benefits package.
• Opportunity to work in a global, innovation-driven environment.
• Commitment to professional development and career growth.
• Inclusive culture focused on accountability and teamwork.