About The Position

Responsible for sustaining and improving manufacturing processes and semi-automated equipment to support safe, compliant, and efficient production within a regulated environment.

Requirements

  • Bachelor's degree in mechanical, Electrical, or related Engineering discipline
  • 2+ years of engineering experience in a regulated manufacturing environment
  • Hands-on experience with mechanical systems, equipment, and tooling
  • Electrical troubleshooting and controls fundamentals
  • Experience supporting or owning semi-automated manufacturing equipment
  • Strong problem-solving and root cause analysis capability

Nice To Haves

  • Medical device manufacturing experience
  • Experience with validation processes (IQ/OQ/PQ) and quality systems
  • Lean / Six Sigma experience
  • Exposure to manufacturing systems (e.g., MES, SAP)
  • Basic familiarity with automated equipment and controls

Responsibilities

  • Maintain and continuously improve established manufacturing processes, tooling, and semi-automated systems
  • Own equipment performance, reliability, and long-term sustainability
  • Troubleshoot mechanical and electrical issues using structured root cause methodologies
  • Drive equipment and process improvements, including error-proofing and uptime optimization
  • Execute validation activities (IQ/OQ/PQ) and maintain technical documentation
  • Ensure compliance with FDA, ISO, and internal quality system requirements
  • Support CAPA, nonconformance investigations, and audit readiness
  • Provide real-time production support and drive continuous improvement initiatives
  • Train and guide technicians and operators on processes and equipment
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