Maintenance Engineer

The Medical Products Division (MPD) Shop Services Team is seeking a skilled and experienced Maintenance Engineer to support medical manufacturing operations and shop services. This role serves as a key technical contributor within the Shop Services organization, working closely with Process Engineers, Quality Engineers, and cross-functional teams to ensure the reliability, compliance, and performance of manufacturing equipment. This position is highly systems-oriented and involves comprehensive responsibilities including equipment assessment, record creation, implementation planning, advanced troubleshooting, and failure trend analysis. The Maintenance Engineer will play a critical role in evaluating and managing assets within the medical division.

This position will be located at our facility in Flagstaff, Arizona, with the possibility of a hybrid work arrangement.

• Integrate maintenance considerations into the design and commissioning phases by actively participating in design reviews and factory acceptance testing (FAT) for new equipment to ensure long-term reliability and serviceability
• Develop and sustain maintenance procedures and schedules for equipment and align with industry best practices and Quality System requirements to ensure consistent performance and regulatory compliance
• Evaluation of new equipment from a maintenance engineering perspective, including preventive maintenance planning, identification of critical operating parameters, and onboarding assets into the Enterprise Asset Management (EAM) system
• Collaborate with shop service teams to document equipment failures accurately, provide technical expertise in troubleshooting, root cause analysis, and coordinate corrective actions with Production Engineering and Quality Assurance
• Ensure data integrity within the EAM system, drive collection and analysis of maintenance metrics, preventative maintenance activities, risk assessments, critical spare parts usage, machine condition monitoring, and service-life evaluations
• Engage daily with cross-functional teams including Design & Automation, Product Engineering, Support Services, and Quality Assurance to support maintenance-related initiatives and resolve equipment issues
• Execute all maintenance engineering tasks in strict alignment with medical manufacturing Quality System standards to ensure compliance and traceability
• Maintain up-to-date training certifications and technical knowledge required for effective maintenance engineering performance
• Support additional maintenance engineering activities as needed to contribute to continuous improvement and operational excellence

• Technical associates degree or military technical school equivelant and minimum of 10 years of hands-on experience as a maintenance technician and/or engineer
• Proficient in interpreting, authoring, and applying maintenance and repair documentation, including schematics, manuals, and work instructions
• Skilled in verifying and processing data from multiple sources using established selection procedures and batch record systems
• Strong understanding of preventive maintenance strategies and industry-standard maintenance practices to ensure equipment reliability and uptime
• Familiarity with relevant regulatory frameworks and standards, including 21 CFR Part 820, ISO 13485, ISO 9001, and NIST guidelines
• Advanced proficiency in Microsoft Excel and Word, with strong typing and transcription capabilities; experience with high-speed data entry systems
• Proven ability to independently and collaboratively diagnose technical issues and implement effective solutions in a timely manner
• Capable of working effectively in cleanroom or controlled manufacturing environments, adhering to strict procedural and safety protocols
• Ability to travel up to 10% as needed to support equipment installations, audits, or cross-site collaboration

• Educational Background: Bachelor's degree in a scientific or engineering discipline
• CMMS Experience: Hands-on experience with Computerized Maintenance Management Systems (CMMS), preferably Infor EAM, including asset tracking, work order management, and preventive maintenance scheduling
• Industry Experience: Prior experience working in regulated environments such as medical device manufacturing, pharmaceuticals, or other industries governed by

This position offers a hybrid work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore's work arrangement policies.