Position Summary

We are seeking a skilled and motivated Equipment & Facilities Engineering Manager 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

• Lead the Equipment and Facilities Engineering function, ensuring reliable operation and maintenance of manufacturing equipment, facility infrastructure, utilities, and support systems.
• Develop and execute equipment and facilities strategies that support production growth, operational excellence, compliance, and business objectives.
• Manage engineering staff, maintenance technicians, contractors, and service providers to ensure effective execution of departmental goals and priorities.
• Oversee preventive, predictive, and corrective maintenance programs to maximize equipment uptime and minimize production interruptions.
• Establish reliability metrics, maintenance KPIs, and asset management programs to improve equipment performance and lifecycle management.
• Lead capital projects including facility expansions, equipment installations, process improvements, utility upgrades, and infrastructure modernization efforts.
• Develop project scopes, budgets, schedules, resource plans, and risk assessments for engineering and facilities projects.
• Support equipment commissioning, qualification, validation, and startup activities, including IQ/OQ/PQ documentation where applicable.
• Manage facility systems including HVAC, electrical distribution, compressed air, water systems, environmental controls, security systems, and other critical infrastructure.
• Ensure proper operation and maintenance of cleanroom and controlled manufacturing environments.
• Partner with Quality and Regulatory Affairs to ensure compliance with ISO 13485, FDA regulations, and applicable industry standards.
• Support internal audits, external audits, supplier audits, inspections, and regulatory assessments.
• Develop and maintain engineering standards, specifications, SOPs, preventive maintenance procedures, and equipment documentation.
• Drive root cause investigations, CAPAs, and corrective actions related to equipment failures, utility interruptions, and facility issues.
• Implement Lean Manufacturing, reliability engineering, and continuous improvement initiatives to improve productivity, quality, and cost performance.
• Manage facility and equipment budgets, including both capital expenditure (CapEx) and operating expenditures (OpEx).
• Evaluate and manage engineering service providers, contractors, equipment suppliers, and maintenance vendors.
• Support new product introductions, process transfers, and manufacturing scale-up initiatives by ensuring facility and equipment readiness.
• Collaborate with Operations, Manufacturing, Quality, Supply Chain, R&D, and EHS to prioritize engineering activities and resolve technical issues.
• Develop and maintain emergency response, business continuity, and facility risk-management plans.
• Provide periodic reporting and performance updates to executive leadership.
• Embody GT Medical's purpose and shared values, building a positive and productive team culture.
• 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.

• Bachelor's degree in Mechanical, Electrical, Industrial, Manufacturing, Chemical Engineering, or related technical discipline.
• Minimum 8 years of experience in facilities engineering, manufacturing engineering, maintenance engineering, reliability engineering, or related technical roles.
• Minimum 4 years of leadership experience managing engineers, maintenance personnel, contractors, or technical teams.
• Experience supporting manufacturing operations in a regulated environment.
• Experience managing facility infrastructure, utilities, manufacturing equipment, and maintenance programs.
• Experience leading capital projects from planning through execution and closeout.
• Demonstrated experience developing and managing preventive maintenance and reliability programs.
• Strong understanding of root cause analysis, troubleshooting, and continuous improvement methodologies.
• Experience managing contractors, vendors, and engineering service providers.
• Strong project management, budgeting, and resource planning skills.
• Excellent written and verbal communication skills.
• Ability to manage multiple priorities within a fast-paced environment.
• Proficiency with Microsoft Office applications including Word, Excel, PowerPoint, and Outlook.

Preferred

• Experience in medical device, pharmaceutical, biotechnology, semiconductor, nuclear, aerospace, or other highly regulated manufacturing environments.
• Working knowledge of ISO 13485, FDA regulations, GMP requirements, and validation principles.
• Experience supporting cleanrooms level 7, controlled environments, or sterile manufacturing operations.
• Experience with equipment qualification and validation activities including IQ/OQ/PQ.
• Experience with CMMS, ERP, and asset management systems.
• Project Management Professional (PMP), Certified Maintenance & Reliability Professional (CMRP), Lean Six Sigma, or similar certifications.
• Experience supporting facility expansions, manufacturing scale-up initiatives, and new equipment implementation projects.

Physical Demands / Working Conditions

• On-site role in a manufacturing environment.
• May require entry into controlled environments (ISO Class 7/8 cleanrooms).
• Occasional off-hours work to support facility or equipment projects.
• Frequent exposure to hazardous materials requiring appropriate PPE and precautions when working with hazardous materials and chemicals.
• Requires frequent finite hand/eye coordination.
• Frequently picks up, carries, and moves items up to 50 lbs.
• Some evening and weekend work depending upon workload.
• Some overnight travel may be required for work, events, and trainings.