Equipment & Facilities Engineer

We are seeking a skilled and motivated Equipment & Facilities Engineer to support and improve production operations in a regulated medical device manufacturing environment. This role is responsible for maintaining and enhancing equipment performance, ensuring facility readiness and compliance, and driving continuous improvement in alignment with FDA, ISO 13485, and cGMP standards.

Job Duties/Responsibilities

• Manufacturing Equipment Support:
  • Manage preventive and corrective maintenance programs for critical manufacturing equipment and infrastructure.
  • Partner with Quality and Regulatory teams to ensure compliance with validation protocols and risk assessments.
  • Troubleshoot mechanical, electrical, pneumatic, and automated systems to minimize downtime.
  • Document changes and maintain equipment-related records per internal quality systems.
• Facilities Engineering:
  • Oversee maintenance and operation of facility infrastructure including cleanrooms, HVAC, water systems, and critical utilities.
  • Support cleanroom compliance, including ISO Class 7/8 areas.
  • Support facility expansions, layout changes, and utility upgrades to accommodate production growth.
  • Ensure EHS and OSHA compliance for facility operations and equipment installations.
  • Manage external contractors and vendors for facility and equipment projects.
  • Assist in root cause analysis and resolution of equipment-related nonconformances and deviations.
  • Support audits and inspections by providing facility and equipment documentation and technical expertise.
  • Monitor and analyze equipment performance data to identify trends and drive continuous improvement.
  • Ensure compliance with applicable building codes, safety regulations, and environmental standards.
  • Coordinate with external contractors and vendors for facility and equipment projects.
  • Comply with Company policies and procedures.
  • Authorized to access employee and/or patient PHI and ePHI only as needed for job-related functions.
  • Other duties as assigned.