What are the responsibilities and job description for the Maintainability Engineer position at Fusion Life Sciences Technologies LLC?
About the Company
Medtronic is a leading global medical technology company that develops and manufactures devices and therapies for conditions like heart disease, diabetes, and neurological disorders.
Responsible for improving equipment maintainability, uptime, and lifecycle performance in a medical device manufacturing environment, ensuring compliance with regulatory standards and supporting efficient, reliable production systems.
Key Responsibilities
- Develop and optimize preventive and predictive maintenance (PM/PdM) for production and utility equipment
- Reduce downtime by improving MTTR, MTBF, and equipment availability
- Perform Root Cause Failure Analysis (RCFA) for equipment failures impacting product quality
- Support asset lifecycle management (LCAM) from installation, qualification (IQ/OQ/PQ), to operation
- Improve equipment design for ease of maintenance and serviceability
- Ensure maintenance activities align with validated state and change control processes
- Collaborate with Quality, Validation, Manufacturing, and Engineering teams
- Support Maintenance Excellence Programs (MEP) and continuous improvement
- Maintain proper documentation for audits and inspections
- Ensure compliance with:
- Food and Drug Administration (21 CFR Part 820 – QSR)
- ISO 13485 (Medical Device QMS)
- Occupational Safety and Health Administration safety standards
Qualifications
- Bachelor’s degree in Engineering (Mechanical/Electrical/Industrial or related)
- 7-10 years of experience in medical device or regulated manufacturing environment
- Experience with equipment qualification (IQ/OQ/PQ) and validated systems
- Knowledge of GMP/GxP, ISO 13485, and 21 CFR Part 820
- Hands-on experience with CMMS/SAP PM/Maximo
- Strong understanding of RCFA, FMEA, CAPA, and change control processes