Facilities & Maintenance Engineer - TPR

Terumo Cardiovascular Group; Caguas (PR); On-site; USD 90,000 - 110,000; Full time

Job summary

Terumo Medical Corporation is seeking a Facilities & Maintenance Engineer to oversee the reliability and lifecycle management of facility systems, utilities, and maintenance programs at its manufacturing sites. You will ensure validated, compliant, and inspection-ready infrastructure supporting GMP, FDA, ISO 13485 and QMS requirements.

The role leads troubleshooting, preventive/predictive maintenance, and continuous improvement initiatives that enable high uptime and cost-effective operations

Qualifications

• Bachelor’s degree in Mechanical, Electrical, Electronic Engineering or related field.
• Minimum 5 years of experience in facilities/maintenance engineering within regulated manufacturing.
• Experience with CMMS optimization and maintenance planning.
• Knowledge of Building Management Systems (BMS).

Responsibilities

• Ensure Reliability of Facility, Utility & Equipment Systems by operating and improving GMP-critical systems.
• Own Preventive & Predictive Maintenance Programs through CMMS; define frequencies, plans, and parts strategies.
• Maintain Compliance with GMP & Regulatory Standards including FDA/ISO 13485; support audits.
• Support Validation, Calibration & Change Control activities (IQ/OQ/PQ, requalification).
• Lead Troubleshooting & Reliability Engineering activities; conduct RCA and CAPAs.
• Drive Continuous Improvement & Asset Lifecycle Management using performance data.
• Support Capital Projects & Engineering Initiatives with design-for-maintainability.
• Ensure EHS & Contractor Safety compliance during maintenance activities.

Skills

Troubleshooting RCA

Maintenance planning

GMP compliance writing

Data analysis

Cross-functional collaboration

Project management

Education

Bachelor’s degree in Mechanical/Electrical/Electronic Engineering or related field

Tools

CMMS optimization

AutoCAD

Building Management Systems (BMS)

Reliability TPM concepts

Job description

Select how often (in days) to receive an alert:

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.

At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.

Join us and help shape wherever we go next!

Advancing healthcare with heart

Job Summary

The Facilities & Maintenance Engineer is responsible for the reliability, compliance, and lifecycle management of facility systems, utilities, and maintenance programs in the manufacturing Sites (TPR1 &TPR2). This role ensures that facility infrastructure and equipment are maintained in a validated, compliant, and inspection-ready state, meeting GMP, FDA, ISO 13485, and internal Quality Management System (QMS) requirements. The position combines engineering expertise and maintenance program ownership, serving as a technical lead for troubleshooting, preventive and predictive maintenance strategies, and continuous improvement initiatives that support manufacturing, laboratory, and warehouse operations.

• Ensure Reliability of Facility, Utility & Equipment Systems
  Operate, monitor, and improve performance of GMP-critical systems (HVAC, electrical, compressed air, water systems, fire protection) and facility-related equipment to ensure high uptime and operational continuity.
• Own Preventive & Predictive Maintenance Programs
  Develop, optimize, and sustain preventive and predictive maintenance strategies through CMMS; define frequencies, job plans, and spare parts strategies to improve reliability and reduce downtime.
• Maintain Compliance with GMP & Regulatory Standards
  Ensure facilities and maintenance activities comply with FDA, ISO 13485, and QMS requirements; maintain audit readiness and support inspections.
• Support Validation, Calibration & Change Control
  Participate in IQ/OQ/PQ, requalification, calibration coordination, and change control activities for facilities, utilities, and maintenance-related systems.
• Lead Troubleshooting & Reliability Engineering Activities
  Diagnose complex equipment and system failures; lead root cause analysis, deviations, and CAPAs to improve long-term reliability.
• Drive Continuous Improvement & Asset Lifecycle Management
  Analyze CMMS and performance data (downtime, MTBF, MTTR); implement improvements in asset performance, maintenance effectiveness, and cost control.
• Support Capital Projects & Engineering Initiatives
  Provide technical input and execution support for installations, upgrades, and facility modifications, ensuring maintainability and compliance by design.
• Ensure EHS & Contractor Safety Compliance
  Support EHS programs, risk assessments, and contractor oversight to ensure safe execution of maintenance and engineering activities.

Job Responsibilities (continued)

Working Conditions/Physical Requirements

Knowledge, Skills and Abilities (KSA)

Knowledge:

GMP regulations (FDA, ISO 13485)

Facilities, utilities, and industrial equipment systems.

Preventive and predictive maintenance methodologies.

CMMS systems and maintenance planning.

Validation and calibration processes.

EHS and OSHA standards.

Skills:

Troubleshooting and root cause analysis (RCA)

Maintenance program development and optimization

Technical documentation and GMP compliance writing

Data analysis (MTBF, MTTR, downtime trends)

Cross-functional collaboration

Solid project management skills, including planning, scheduling, resource coordination, and execution of facility and maintenance projects within GMP-regulated environments.

Abilities:

Ability to manage multiple priorities in a regulated manufacturing environment

Ability to make sound engineering and maintenance decisions

Ability to influence without authority

Ability to communicate effectively in English (written and verbal)

Qualifications/ Background Experiences

Education: Bachelor’s Degree in Science of Mechanical Engineering, Electrical Engineering, Electronic Engineering or any Engineering related field.

Work Experience: Minimum 5 years of experience in facilities and/or maintenance engineering within regulated manufacturing (medical devices, pharmaceutical, biotech)

Certifications / Domain Expertise (Preferred):

Experience with CMMS optimization and maintenance planning

Experience supporting validated utilities and systems

Knowledge of Building Management Systems (BMS)

AutoCAD or technical drawing review

Reliability engineering or TPM concepts

Other Requirements / Attributes:

Strong compliance and quality mindset

It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.

Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program.