Position Summary:
The Maintenance Manager is responsible for the reliability, performance, and continuous improvement of all manufacturing equipment, facilities, utilities, and critical plant systems within a regulated medical device manufacturing environment. This role leads a multi-skilled maintenance team supporting injection molding, high-speed automation, HVAC, electrical, and facility infrastructure systems. The manager drives asset reliability, preventive and predictive maintenance programs, operational excellence initiatives, capital projects, and CMMS optimization while ensuring compliance with safety, quality, FDA, GMP, and OSHA requirements. This position partners closely with Engineering, Operations, Quality, and EHS to maximize uptime, improve OEE, reduce costs, and support business growth.
This role is 100% onsite at our Dublin, OH manufacturing facility.
Essential Duties & Responsibilities:
Leadership & Strategy
- Lead, coach, and develop maintenance and facilities personnel to achieve safety, reliability, quality, and productivity objectives.
- Develop and execute the site maintenance strategy aligned with TPM, reliability-centered maintenance, and operational excellence principles.
- Establish department goals, KPIs, budgets, and performance metrics to drive accountability and continuous improvement.
Reliability & Asset Management
- Drive equipment reliability through preventive, predictive, and condition-based maintenance programs.
- Utilize CMMS systems to manage work orders, maintenance planning, asset history, and spare parts inventory.
- Analyze equipment performance data and implement corrective actions to improve asset uptime and Overall Equipment Effectiveness (OEE).
- Lead root cause investigations for equipment failures and recurring downtime events.
Safety, Compliance & Quality
- Maintain a safe, compliant, and audit-ready facility through adherence to FDA, GMP, OSHA, and company requirements.
- Ensure maintenance activities are executed in accordance with approved procedures, quality standards, and regulatory requirements.
- Lead and support EHS investigations, corrective actions, and risk reduction initiatives.
Facilities & Utilities Management
- Oversee the maintenance and performance of facility systems including HVAC, boilers, chilled water, compressed air, fire protection, DI water, vacuum systems, and building infrastructure.
- Manage contractor and vendor relationships, service agreements, permits, and project execution.
Continuous Improvement & Capital Projects
- Identify and lead cost reduction, energy efficiency, sustainability, and reliability improvement projects.
- Manage capital projects from concept through implementation, including budgeting, scheduling, validation support, and startup activities.
- Collaborate with Engineering and Operations to evaluate and implement new technologies and process improvements.
Knowledge, Skills & Qualifications:
- Strong leadership, communication, coaching, and team development skills.
- Demonstrated expertise in maintenance management within a regulated manufacturing environment.
- Extensive knowledge of injection molding equipment, robotics, automation, packaging systems, and supporting utilities.
- Proficiency with CMMS platforms and maintenance planning methodologies.
- Strong background in TPM, Lean Manufacturing, Six Sigma, and continuous improvement initiatives.
- Experience conducting root cause analysis using structured problem-solving methodologies.
- Knowledge of FDA, GMP, ISO, OSHA, and other applicable regulatory requirements.
- Ability to manage budgets, capital expenditures, and maintenance-related financial performance.
- Proficiency in Microsoft Office Suite and maintenance reporting systems
Education and Experience:
Required
- Must be 18 years of age
- Bachelor's degree in engineering, Industrial Technology, Facilities Management, or related field; equivalent experience considered.
- 7+ years of maintenance experience within medical device manufacturing, pharmaceutical, or highly regulated manufacturing environments.
- Minimum 5 years leading maintenance, facilities, or reliability teams.
- Demonstrated success managing preventive maintenance programs, capital projects, regulatory compliance, and asset reliability initiatives.
Preferred
- Certified Maintenance & Reliability Professional (CMRP).
- Lean Six Sigma Green Belt or higher.
- Experience supporting ISO 13485 or FDA regulated manufacturing operations
Physical Requirements and Work Environment:
- Most activities will occur within a manufacturing clean room environment with some office requirements
- Work tasks may be periodically performed outside or on the roof.
- Work tasks may take place in a clean room manufacturing environment requiring the use of appropriate gowning and/or PPE.
- May need to stand for extended periods of time.
- Walk, climb stairs, respond to color or special visual indicators.
- Periodically, must be able to lift to 50 lbs. without assistance (equipment, parts etc.)
- Typically requires travel less than 10% of the time
ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.
With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.
We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:
- Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
- The industry's broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
- IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
- Significant US IV solutions manufacturing and supply capabilities.
ICU Medical EEO Statement:
ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.
If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.
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